CataractPhase 1/2NCT06681688
Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC
A Phase 1/2 study testing Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} and Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte} in people with Cataract, run by Inder Paul Singh, M.D. at 2 sites in United States.
Trial summary
This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} and Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2024to Aug 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Adult participants > 18 years of age undergoing bilateral cataract surgery
- Able to provide written informed consent prior to any study related procedure
- Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
- Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months
- Participants who do not meet the exclusion criteria may be enrolled.
Who cannot join
- Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
- Glaucoma patients or known steroid responders
- Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
- Intraocular injection within 6 months
- Any prior ocular implant
- Diagnosis of retinal thickening in the study eye within 12 months of enrollment
- Inability to provide informed consent
- Participation in another clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Eye Centers of Racine & Kenosha
Racine, Wisconsin, 53405
Paul Singh, MD, 262-637-0500, ipsingh@amazingeye.com
- Recruiting
The Eye Associates - Venice
Venice, Florida, 34292
Cathleen McCabe, MD, 941-493-3763, cmccabe131@hotmail.com
About this study
Official title: Prospective Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative Standard of Care
This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.
Read the detailed description
For the control arm interventions:
Preoperatively, the Control Arm (control eye) will self-administer a regimen of ketorolac four times daily (QID) x 1 day and moxifloxacin drops three times daily (TID) x 1 day before surgery. On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule:
- In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin
- Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin
- At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate
- Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate
Eyes in the Control Arm will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month, prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.
For the study arm interventions:
Eyes will receive in-office drops on the Day of Surgery administered by study staff according to the following schedule:
- In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin
- Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin
- At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate
- Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate.
Eyes in the Study Arm will be treated with the following intraoperative interventions: intracameral phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin, and subconjunctival triamcinolone acetonide.
The following study assessments will take place for all subjects:
Visual acuity measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (pinhole visual acuity [VA] or best corrected visual acuity [BCVA])
- Slit lamp examination, including intraocular pressure (IOP) measurement
- Grading of inflammation
- Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire
- Pain assessment on a 0-4 scale
- Overall participant satisfaction on a 0-10 scale
- Optical coherence tomography (OCT) imaging
Eyes in the Study Arm will also receive in-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate.
Rescue therapy for postoperative inflammation will be allowed for Study Arm participants, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate QID (taper also at the discretion of the evaluating physician).
- Conditions
- Cataract
- Being tested
- Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}, Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}
- Keywords
- OMIDRIA
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}Drug
Also called (OMIDRIA), Phenylephrine (1%) and Ketorolac (0.3%) intraocular solution
Eyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL).
Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}Drug
Also called TORADOL (Generic), Vigamox, Avalox, Pred Forte, Prelone, Omnipred
On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule:
- In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
- Immediately prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
- At the conclusion of surgery while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%)
- Any time in postoperative recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%)
| Study group | Role | What they receive |
|---|---|---|
| Study Arm (OMIDRIA) | Experimental | * Pre-op, 1 drop ketorolac (0.5%) {Toradol}, 1 drop moxifloxacin (0.5%) {Avelox}
* Prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
* Concl. of surgery while still in the OR: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) {Pred Forte}
* Post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).
Intraoperative interventions: intracameral phenylephrine {Sudafed} 1.0%/ketorolac 0.3%, {OMIDRIA} intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10 mg/mL) {Kenalog}.
In-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).
Rescue therapy will be allowed, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate (1%) QID (taper also at the discretion of the evaluating physician). Receives: Drug: Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} |
| Control Arm (Standard of Care) | Active comparator | Self-administration of:
Ketorolac (0.5%) {Toradol} four times daily (QID) x 1 day and moxifloxacin (0.5%) {Avelox} drops three times daily (TID) x 1 day before SX.
On the Day of SX, eyes will receive in-office drops administered by study staff according to the following:
* In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
* Immediately prior to SX: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
* At the conclusion of SX while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) Pred Forte}
* Any time in post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).
Eyes will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month. Prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week. Receives: Drug: Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte} |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation
The proportion of participants with inflammation on Day 8. (Participants will be considered to have no inflammation (Grade 0) if they have ≤ 2 anterior chamber cells and are asymptomatic.) {Anterior Inflammation Scale, 0-4 with 4 being the worst or most severe score}
Measured: 8 days
Secondary outcomes (1)
SPEED Questionnaire
Mean change in SPEED Questionnaire from baseline to Day 8 and baseline to Day 30
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start10 Jul 2024
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2-arm non-inferiority trial with the following arms: * Control arm: Participants undergoing cataract surgery using conventional standard of care peri-operative eyedrops. * Study arm: Participants undergoing cataract surgery with a regimen of peri-operative topical eyedrops administered to the participant by study staff, in combination with intracameral phenylephrine 1.0%/ketorolac 0.3%, subconjunctival triamcinolone acetonide, and intracameral moxifloxacin.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inder Paul Singh, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- The Eye Associates
- Responsible party
- Sponsor-investigator, Inder Paul Singh, M.D., The Eye Centers of Racine and Kenosha
- Investigators
- Paul Singh, MD, Principal investigator, The Eye Centers of Racine & Kenosha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681688
- Sponsor's protocol ID
- MSS V2 6324
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative Standard of Care
- ClinicalTrials.gov ID
- NCT06681688
- Acronym / sponsor ID
- MSS V2 6324
- Conditions
- Cataract
- Keywords
- OMIDRIA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Inder Paul Singh, M.D.University, hospital or other
- Collaborators
- The Eye Associates
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.
Detailed description
For the control arm interventions:
Preoperatively, the Control Arm (control eye) will self-administer a regimen of ketorolac four times daily (QID) x 1 day and moxifloxacin drops three times daily (TID) x 1 day before surgery. On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule:
- In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin
- Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin
- At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate
- Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate
Eyes in the Control Arm will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month, prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.
For the study arm interventions:
Eyes will receive in-office drops on the Day of Surgery administered by study staff according to the following schedule:
- In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin
- Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin
- At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate
- Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate.
Eyes in the Study Arm will be treated with the following intraoperative interventions: intracameral phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin, and subconjunctival triamcinolone acetonide.
The following study assessments will take place for all subjects:
Visual acuity measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (pinhole visual acuity [VA] or best corrected visual acuity [BCVA])
- Slit lamp examination, including intraocular pressure (IOP) measurement
- Grading of inflammation
- Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire
- Pain assessment on a 0-4 scale
- Overall participant satisfaction on a 0-10 scale
- Optical coherence tomography (OCT) imaging
Eyes in the Study Arm will also receive in-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate.
Rescue therapy for postoperative inflammation will be allowed for Study Arm participants, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate QID (taper also at the discretion of the evaluating physician).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a 2-arm non-inferiority trial with the following arms: * Control arm: Participants undergoing cataract surgery using conventional standard of care peri-operative eyedrops. * Study arm: Participants undergoing cataract surgery with a regimen of peri-operative topical eyedrops administered to the participant by study staff, in combination with intracameral phenylephrine 1.0%/ketorolac 0.3%, subconjunctival triamcinolone acetonide, and intracameral moxifloxacin.
| Arm | Type | Receives |
|---|---|---|
| Study Arm (OMIDRIA) | Experimental | Drug: Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}* Pre-op, 1 drop ketorolac (0.5%) {Toradol}, 1 drop moxifloxacin (0.5%) {Avelox} * Prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Concl. of surgery while still in the OR: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) {Pred Forte} * Post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Intraoperative interventions: intracameral phenylephrine {Sudafed} 1.0%/ketorolac 0.3%, {OMIDRIA} intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10 mg/mL) {Kenalog}. In-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Rescue therapy will be allowed, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate (1%) QID (taper also at the discretion of the evaluating physician). |
| Control Arm (Standard of Care) | Active comparator | Drug: Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}Self-administration of: Ketorolac (0.5%) {Toradol} four times daily (QID) x 1 day and moxifloxacin (0.5%) {Avelox} drops three times daily (TID) x 1 day before SX. On the Day of SX, eyes will receive in-office drops administered by study staff according to the following: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to SX: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of SX while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) Pred Forte} * Any time in post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%). Eyes will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month. Prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult participants > 18 years of age undergoing bilateral cataract surgery
- Able to provide written informed consent prior to any study related procedure
- Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
- Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months
- Participants who do not meet the exclusion criteria may be enrolled.
Key exclusion criteria (8 listed)
- Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
- Glaucoma patients or known steroid responders
- Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
- Intraocular injection within 6 months
- Any prior ocular implant
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 |
|---|---|---|
| Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}Also: (OMIDRIA), Phenylephrine (1%) and Ketorolac (0.3%) intraocular solutionEyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL). | Drug | Study Arm (OMIDRIA) |
| Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}Also: TORADOL (Generic), Vigamox, Avalox, Pred Forte, Prelone, OmnipredOn the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of surgery while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) * Any time in postoperative recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) | Drug | Control Arm (Standard of Care) |
Primary outcome
inflammation
Time frame: 8 days
The proportion of participants with inflammation on Day 8. (Participants will be considered to have no inflammation (Grade 0) if they have ≤ 2 anterior chamber cells and are asymptomatic.) {Anterior Inflammation Scale, 0-4 with 4 being the worst or most severe score}
1 secondary outcome
SPEED Questionnaire
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Paul Singh, MD principal investigator
The Eye Centers of Racine & Kenosha
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} and Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte} in people with Cataract, run by Inder Paul Singh, M.D. at 2 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Singh, MD (262-637-0500, ipsingh@amazingeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation (time frame: 8 days). 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 29 Nov 2024.