CataractPhase 2NCT01193127
Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
A Phase 2 study testing OMS302 Solution, OMS302 Mydriatic Solution and OMS302 Anti-inflammatory Solution in people with Cataract, run by Omeros Corporation at 24 sites in United States.
Trial summary
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- OMS302 Solution, OMS302 Mydriatic Solution and OMS302 Anti-inflammatory Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 24 sitesUnited States
- Study dates
- Jul 2010to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent and willing to voluntarily provide informed consent
- 18 years of age or older
- In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
- Other inclusion criteria to be evaluated by the investigator
Who cannot join
- No allergies to the medications and/or the active ingredients of any of the study medications
- No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
- No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
- Other exclusion criteria to be evaluated by the investigator
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Study site
Albuquerque, New Mexico, 87113
Study site
Austin, Texas, 78731
Study site
Bala-Cynwyd, Pennsylvania, 19004
Study site
Chandler, Arizona, 85224
Study site
Glendale, Arizona, 85308
Study site
Goodlettsville, Tennessee, 37072
Study site
Gretna, Louisiana, 70056
Study site
Gurnee, Illinois, 60031
Study site
Houston, Texas, 77024
Study site
Kansas City, Missouri, 64111
Study site
Largo, Florida, 33770
Study site
Las Vegas, Nevada, 89135
Study site
Little Rock, Arkansas, 72205
Study site
Los Angeles, California, 90013
Study site
Nacogdoches, Texas, 75965
Study site
North Fort Myers, Florida, 33903
Study site
Omaha, Nebraska, 68131
Study site
Panama City, Florida, 32405
Study site
Parker, Colorado, 80134
Study site
Rockville Centre, New York, 11570
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
St Louis, Missouri, 63131
Study site
Tamarac, Florida, 33321
About this study
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
- Conditions
- Cataract
- Being tested
- OMS302 Solution, OMS302 Mydriatic Solution, OMS302 Anti-inflammatory Solution, Balanced Salt Solution (BSS) Solution
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS302 SolutionDrug
OMS302 Mydriatic SolutionDrug
OMS302 Anti-inflammatory SolutionDrug
Balanced Salt Solution (BSS) SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| OMS302 Solution | Experimental | OMS302 Solution Receives: Drug: OMS302 Solution |
| OMS302 Mydriatic Solution | Experimental | OMS302 Mydriatic Solution Receives: Drug: OMS302 Mydriatic Solution |
| OMS302 Anti-inflammatory Solution | Experimental | OMS302 Anti-inflammatory Solution Receives: Drug: OMS302 Anti-inflammatory Solution |
| Balanced Salt Solution (BSS) Solution | Placebo comparator | Balanced Salt Solution (BSS) Solution Receives: Drug: Balanced Salt Solution (BSS) Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil Diameter (mm) During Surgery
Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.
Measured: During surgery (immediately prior to surgical incision to wound closure)
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively
For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.
Measured: through 12 hours post-surgery
Secondary outcomes (72)
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two hours
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Six hours
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: One day
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two days
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Seven days
Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: 14 days
Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: up to 30 days
Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two hours
Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Six hours
Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: One day
Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two days
Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Seven days
Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: 14 days
Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two hours
Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Six hours
Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: One day
Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two days
Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Seven days
Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: 14 days
Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two hours
Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Six hours
Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: One day
Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two days
Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Seven days
Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: 14 days
Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two hours
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Six hours
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: One day
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Seven days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: 14 days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two hours
Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Six hours
Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: One day
Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Two days
Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Seven days
Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: 14 days
Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination
The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: Up to 30 days
Best Corrected Visual Acuity (BVCA) - Log Score, Baseline
Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Measured: Baseline
Best Corrected Visual Acuity (BVCA) - Log Score, Day 1
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Measured: One day
Best Corrected Visual Acuity (BVCA) - Log Score, Day 2
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Measured: Two days
Best Corrected Visual Acuity (BVCA) - Log Score, Day 7
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Measured: Seven days
Best Corrected Visual Acuity (BVCA) - Log Score, Day 14
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Measured: 14 days
Best Corrected Visual Acuity (BVCA) - Log Score, Day 30
Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Measured: 30 days
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Baseline
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery
TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Two hours
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: One day
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Two days
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Seven days
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: 14 days
Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30
Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: 30 days
Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Baseline
Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Two hours
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: One day
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Two days
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: Seven days
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: 14 days
Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30
Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.
Grading was as follows:
Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.
Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Measured: 30 days
Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Measured: Two hours
Postoperative Mean Anterior Chamber Cell Count, Day 1
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Measured: One day
Postoperative Mean Anterior Chamber Cell Count, Day 2
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Measured: Two days
Postoperative Mean Anterior Chamber Cell Count, Day 7
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Measured: Seven days
Postoperative Mean Anterior Chamber Cell Count, Day 14
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Measured: 14 days
Postoperative Mean Anterior Chamber Cell Count, Day 30
The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Measured: 30 days
Ocular Pain VAS Score After Day 0
VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.
Measured: 43 days
Postoperative Use of Ophthalmic Anti-inflammatory Medications
Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: up to 30 days
Use of Pain Medications at Day 1
Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: One day
Use of Pain Medications After Day 1
Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193127
- Sponsor's protocol ID
- C09-001
- Status last verified
- Aug 2014
- First submitted
- 23 Aug 2010
- Last updated
- 28 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
- ClinicalTrials.gov ID
- NCT01193127
- Acronym / sponsor ID
- C09-001
- Conditions
- Cataract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OMS302 Solution | Experimental | Drug: OMS302 SolutionOMS302 Solution |
| OMS302 Mydriatic Solution | Experimental | Drug: OMS302 Mydriatic SolutionOMS302 Mydriatic Solution |
| OMS302 Anti-inflammatory Solution | Experimental | Drug: OMS302 Anti-inflammatory SolutionOMS302 Anti-inflammatory Solution |
| Balanced Salt Solution (BSS) Solution | Placebo comparator | Drug: Balanced Salt Solution (BSS) SolutionBalanced Salt Solution (BSS) Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Competent and willing to voluntarily provide informed consent
- 18 years of age or older
- In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
- Other inclusion criteria to be evaluated by the investigator
Key exclusion criteria (4 listed)
- No allergies to the medications and/or the active ingredients of any of the study medications
- No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
- No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
- Other exclusion criteria to be evaluated by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMS302 Solution | Drug | OMS302 Solution |
| OMS302 Mydriatic Solution | Drug | OMS302 Mydriatic Solution |
| OMS302 Anti-inflammatory Solution | Drug | OMS302 Anti-inflammatory Solution |
| Balanced Salt Solution (BSS) Solution | Drug | Balanced Salt Solution (BSS) Solution |
Primary outcome
Pupil Diameter (mm) During Surgery
Time frame: During surgery (immediately prior to surgical incision to wound closure)
Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively
Time frame: through 12 hours post-surgery
For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.
72 secondary outcomes
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery
Time frame: Two hours
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery
Time frame: Six hours
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery
Time frame: One day
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery
Time frame: Two days
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery
Time frame: Seven days
Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery
Time frame: 14 days
Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination
Time frame: up to 30 days
Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery
Time frame: Two hours
Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery
Time frame: Six hours
Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery
Time frame: One day
Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery
Time frame: Two days
Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery
Time frame: Seven days
Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery
Time frame: 14 days
Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination
Time frame: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery
Time frame: Two hours
Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery
Time frame: Six hours
Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery
Time frame: One day
Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery
Time frame: Two days
Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery
Time frame: Seven days
Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery
Time frame: 14 days
Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination
Time frame: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery
Time frame: Two hours
Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery
Time frame: Six hours
Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery
Time frame: One day
Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery
Time frame: Two days
Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery
Time frame: Seven days
Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery
Time frame: 14 days
Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination
Time frame: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery
Time frame: Two hours
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery
Time frame: Six hours
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery
Time frame: One day
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery
Time frame: Two days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days
Time frame: Seven days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery
Time frame: 14 days
Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination
Time frame: Up to 30 days
Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery
Time frame: Two hours
Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery
Time frame: Six hours
Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery
Time frame: One day
Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery
Time frame: Two days
Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery
Time frame: Seven days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OMS302 Solution, OMS302 Mydriatic Solution and OMS302 Anti-inflammatory Solution in people with Cataract, run by Omeros Corporation at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil Diameter (mm) During Surgery (time frame: During surgery (immediately prior to surgical incision to wound closure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.