Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198445

Enrollment

527

Registered

2005-09-20

Start date

2003-05-31

Completion date

2004-01-31

Last updated

2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Cataract

Keywords

Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal

Brief 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.

Interventions

DRUGBromfenac

One drop in study eye every 12 hours for 14 days

DRUGPlacebo

One drop in study eye every 12 hours for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cataract surgery * Summed ocular inflammation score (anterior chamber cell score plus flare score) of \>/= 3, 24 hours after the cataract extraction * Agreed to avoid disallowed medications (meds) throughout the duration of the study

Exclusion criteria

* Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol * Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye) * Extraocular/intraocular inflammation in either eye * Clinically significant (WHO CTC Grade 1 or greater) liver function tests

Design outcomes

Primary

Measure	Time frame	Description
Ocular Inflammation Score	Visit 4 (Day 15)	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

Secondary

Measure	Time frame	Description
Mean Ocular Inflammation Score	At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)	Mean change from baseline in SOIS at each visit.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026