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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.

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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

FieldValue
Enrollment Target 527 participants
Start Date 2003-05
Est. Completion 2004-01
Phase Phase 3
Bausch & Lomb Incorporated

174 total trials

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.

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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Source: ClinicalTrials.gov NCT00198445, the US trial registry maintained by the National Library of Medicine. NCT00198445 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.