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NCT00198445 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 527
- Enrollment target
NCT00198445: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT00198445 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 527 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00198445, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 527 participants
- Enrollment target
Study Summary
The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.
Primary Outcome
Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none
Interventions
- DRUG Placebo
- DRUG Bromfenac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 527 participants |
| Start Date | 2003-05 |
| Est. Completion | 2004-01 |
| Phase | Phase 3 |
What the finished NCT00198445 record still lists
NCT00198445 is an interventional study that assigns participants to a tested intervention. The registered 527 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00198445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00198445 about?
NCT00198445 is a clinical study titled "Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery". The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety a...
What is the current status of trial NCT00198445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 527 participants. The study started on 2003-05. Estimated completion is 2004-01.
What interventions are being tested in trial NCT00198445?
The interventions under investigation include: Placebo (DRUG), Bromfenac (DRUG).
Who is sponsoring clinical trial NCT00198445?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00198445's enrollment target sits among peer trials
527 715th of 2000 higher than 1,286 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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