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NCT06681688 · ClinicalTrials.gov registry record · Phase 1
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 study of Cataract, sponsored by Inder Paul Singh, M.D..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
- 2
- Study locations
NCT06681688: Recruiting Phase 1 study of Cataract, sponsored by Inder Paul Singh, M.D..
NCT06681688 is a Phase 1 study of Cataract that is actively recruiting participants, run by Inder Paul Singh, M.D.. The registered enrollment target is 94 participants, below the 227-participant average among 83 other Cataract trials with a reported enrollment target (59% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06681688, a Phase 1 study of Cataract, is actively recruiting participants, sponsored by Inder Paul Singh, M.D..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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}
Conditions Studied
Interventions
- DRUG Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}
- DRUG Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}
Study Locations (2)
Florida
- The Eye Associates - Venice - Venice
Wisconsin
- The Eye Centers of Racine & Kenosha - Racine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2025-08 |
| Phase | Phase 1 |
What NCT06681688 shows while recruiting
NCT06681688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 227-participant average among 83 other Cataract trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 2 interventions - of which Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} is the first listed.
NCT06681688 reports a single indexed study location in Florida, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06681688 about?
NCT06681688 is a clinical study titled "Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC". 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.
What is the current status of trial NCT06681688?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2024-07-10. Estimated completion is 2025-08.
What conditions does trial NCT06681688 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT06681688?
The interventions under investigation include: Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide} (DRUG), Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte} (DRUG).
Who is sponsoring clinical trial NCT06681688?
This trial is sponsored by Inder Paul Singh, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06681688 being conducted?
This trial has 2 study locations across Florida, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06681688's enrollment target sits among peer trials
94 41st of 83 higher than 42 of 83 other Cataract trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cataract trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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