NCT00198445

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Complications
• Cataract

Interventions

Type	Name	Description
DRUG	Bromfenac	One drop in study eye every 12 hours for 14 days
DRUG	Placebo	One drop in study eye every 12 hours for 14 days

Timeline

• Start date: 2003-05-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2005-09-20
• Last updated: 2013-03-14

Locations

39 sites across 1 country: United States