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

Phase 3CompletedNCT00198445

Bausch & Lomb Incorporated527 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

527

Conditions

Postoperative Complications Cataract

Interventions

BromfenacDRUG

One drop in study eye every 12 hours for 14 days

PlaceboDRUG

One drop in study eye every 12 hours for 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (39)

Outcomes

Primary Outcomes

Ocular Inflammation Score

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

Time frame: Visit 4 (Day 15)

Secondary Outcomes

Mean Ocular Inflammation Score

Mean change from baseline in SOIS at each visit.

Time frame: At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)

Data from ClinicalTrials.gov

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Harold A Helms, MD

Birmingham, Alabama, United States

Eye Care Arkansas, PA

Little Rock, Arkansas, United States

UCI, Department of Ophthalmology

Irvine, California, United States

Anesthetic Eye Care Institute

Newport Beach, California, United States

Richard A Lewis, MD

Sacramento, California, United States

Eye Care of San Diego

San Diego, California, United States

Santa Clara Valley Medical Center

San Jose, California, United States

E Randy Craven, MD

Littleton, Colorado, United States

The Eye Care Group

New Haven, Connecticut, United States

Cohen Laser Vision Center

Boca Raton, Florida, United States

...and 29 more locations