Intraocular Lens ReplacementPhase 3OMS302-ILR-004NCT01579565
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
A Phase 3 study testing OMS302 in people with Intraocular Lens Replacement, run by Omeros Corporation at 14 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Lens Replacement
- What is being tested?
- OMS302
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Apr 2012to Jan 2013
- Phase
- Phase 3
- 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 or lens extraction with lens replacement surgery in one eye, under topical anesthesia
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 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Study site
Albuquerque, New Mexico, 87113
Study site
Austin, Texas, 78731
Study site
Boston, Massachusetts, 02114
Study site
Chandler, Arizona, 85224
Study site
Fort Myers, Florida, 33901
Study site
Goodlettsville, Tennessee, 37072
Study site
Houston, Texas, 77024
Study site
Los Angeles, California, 90013
Study site
New York, New York, 10021
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
St Louis, Missouri, 63131
Study site
Washington, Missouri, 63090
About this study
Official title: A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
- Conditions
- Intraocular Lens Replacement
- Being tested
- OMS302, Placebo
- Keywords
- cataract, lens replacement
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS302Drug
OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced saline salt (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
PlaceboDrug
Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
| Study group | Role | What they receive |
|---|---|---|
| OMS302 | Experimental | OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. Receives: Drug: OMS302 |
| Placebo | Placebo comparator | Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery
The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.
Measured: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)
Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively
The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.
Measured: 12 hours postoperatively
Secondary outcomes (10)
Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up
The number of subjects with pupil diameter of at least 6 mm at the completion of cortical clean up summarized by treatment arm. The last pupil diameter was used if not available at completion of cortical clean up.
Measured: at time of cortical clean-up (i.e., end of surgical procedure)
Pupil Diameter Less Than 6 mm Anytime During Surgery
The number of subjects with pupil diameter less than 6 mm at any time during surgery summarized by treatment arm.
Measured: Intraoperative
Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively
The number of subjects with moderate -to-severe pain (VAS greater than or equal to 40) at any time point during 12 hours postoperatively summarized by treatment arm.
Measured: 12 hours postoperatively
Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively
The number of subjects who report ocular pain-free status (VAS equal to 0) at all time points during 12 hours postoperatively summarized by treatment arm. Subjects with missing VAS scores during the 12 hours postoperatively were considered as not being pain-free.
Measured: 12 hours postoperatively
Ocular Pain VAS Score on Day 1
VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time point.
Measured: One day postoperatively
Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 6 Hours Post-Surgery
Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point.
Measured: Six hours postoperatively
Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 1 Day Post-Surgery
Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point.
Measured: One day postoperatively
Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on 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 postoperatively
Postoperative Best Corrected Visual Acuity (BVCA) on Day 1
Best Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. The reason for missing scores (e.g., subject could not read enough letters to obtain a score or refraction was not completed) was also summarized. 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.
Measured: One day postoperatively
Systemic Pharmacokinetics (PK) of OMS302
Systemic pharmacokinetics (PK) of phenylephrine (PE) and ketorolac (KE) were performed in a subset of subjects. Descriptive summary statistics for area-under-the-serum-concentration-time curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), and terminal phase half-life (t1/2) were to be generated if measured plasma concentrations were adequate for analysis. Descriptive statistics for pharmacokinetics were not performed as detected concentrations were low and insufficient for analysis.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionJan 2013
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 Intraocular Lens ReplacementStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Whitaker, MD, Study director, Omeros Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579565
- Sponsor's protocol ID
- OMS302-ILR-004
- Acronym
- OMS302-ILR-004
- Status last verified
- Aug 2014
- First submitted
- 13 Apr 2012
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
- ClinicalTrials.gov ID
- NCT01579565
- Acronym / sponsor ID
- OMS302-ILR-004 / OMS302-ILR-004
- Conditions
- Intraocular Lens Replacement
- Keywords
- cataract, lens replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Posted 22 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 the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMS302 | Experimental | Drug: OMS302OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Competent and willing to voluntarily provide informed consent
- 18 years of age or older
- In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia
Key exclusion criteria (3 listed)
- No allergies to the medications and/or the active ingredients of any of the study medications
- No medications with the same activities 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
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 |
|---|---|---|
| OMS302OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced saline salt (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS. | Drug | OMS302 |
| PlaceboPlacebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS. | Drug | Placebo |
Primary outcome
Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery
Time frame: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)
The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.
Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively
Time frame: 12 hours postoperatively
The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.
10 secondary outcomes
Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up
Time frame: at time of cortical clean-up (i.e., end of surgical procedure)
Pupil Diameter Less Than 6 mm Anytime During Surgery
Time frame: Intraoperative
Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively
Time frame: 12 hours postoperatively
Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively
Time frame: 12 hours postoperatively
Ocular Pain VAS Score on Day 1
Time frame: One day postoperatively
Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 6 Hours Post-Surgery
Time frame: Six hours postoperatively
Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 1 Day Post-Surgery
Time frame: One day postoperatively
Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1
Time frame: One day postoperatively
Postoperative Best Corrected Visual Acuity (BVCA) on Day 1
Time frame: One day postoperatively
Systemic Pharmacokinetics (PK) of OMS302
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Steve Whitaker, MD study director
Omeros Corporation
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OMS302 in people with Intraocular Lens Replacement, run by Omeros Corporation at 14 sites in 2 countries.
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 3 inclusion and 3 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 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?
Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery (time frame: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/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 14 Jun 2017.