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

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Bromfenac; Ophthalmic Solutions

Criteria

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