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

NCT ID: NCT00333918

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 522 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-03-31

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.

Conditions

Pain; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1-bromfenac ophthalmic solution

sterile ophthalmic solution

Group Type: EXPERIMENTAL

bromfenac ophthalmic solution

Intervention Type: DRUG

2-placebo comparator

sterile ophthalmic solution

Group Type: PLACEBO_COMPARATOR

placebo comparator

Intervention Type: DRUG

Interventions

bromfenac ophthalmic solution

Intervention Type: DRUG

placebo comparator

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Bianca, PhD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

Irvine, California, United States

Countries

United States

Other Identifiers

ISTA-BR-CS02

Identifier Type: -

Identifier Source: org_study_id