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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Inflammation; Pain

Treatments: Drug: placebo comparator; Drug: bromfenac ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333918

ISTA-BR-CS02

Details and patient eligibility

About

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.

Enrollment: 522 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• Known hypersensitivity to bromfenac and salicylates

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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522 participants in 2 patient groups, including a placebo group

1-bromfenac ophthalmic solution

Experimental group

Description:

sterile ophthalmic solution

Treatment:

Drug: bromfenac ophthalmic solution

2-placebo comparator

Placebo Comparator group

Description:

sterile ophthalmic solution

Treatment:

Drug: placebo comparator