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

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT00333918

Collaborator

(none)

522

Enrollment

Location

Arms

Duration (Months)

58.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Inflammation	Drug: bromfenac ophthalmic solution Drug: placebo comparator	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

522 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1-bromfenac ophthalmic solution sterile ophthalmic solution	Drug: bromfenac ophthalmic solution
Placebo Comparator: 2-placebo comparator sterile ophthalmic solution	Drug: placebo comparator

Arm

Intervention/Treatment

Experimental: 1-bromfenac ophthalmic solution

sterile ophthalmic solution

Drug: bromfenac ophthalmic solution

Placebo Comparator: 2-placebo comparator

sterile ophthalmic solution

Drug: placebo comparator

Outcome Measures

Primary Outcome Measures

Reduction of ocular inflammation []

Secondary Outcome Measures

Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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