Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Phase 3

Completed

• Conditions: Pain; Inflammation
• Interventions: Drug: bromfenac ophthalmic solution; Drug: placebo comparator

• Registration Number: NCT00333918
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-04
• Study First Submitted QC: 2006-06-05
• Study First Posted: 2006-06-06
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 522

Inclusion Criteria

• Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
• Agree to return for all required visits
• Agree to avoid disallowed medications

Exclusion Criteria

• Known hypersensitivity to bromfenac and salicylates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-bromfenac ophthalmic solution	bromfenac ophthalmic solution	sterile ophthalmic solution
2-placebo comparator	placebo comparator	sterile ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Reduction of ocular inflammation

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free