Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Postoperative Complications; Cataract

Treatments: Drug: Placebo; Drug: Bromfenac

Study type: Interventional

Funder types: Industry

Identifiers

NCT00198445

ISTA-BR-CS001

Details and patient eligibility

About

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.

Enrollment: 527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cataract surgery
• Summed ocular inflammation score (anterior chamber cell score plus flare score) of >/= 3, 24 hours after the cataract extraction
• Agreed to avoid disallowed medications (meds) throughout the duration of the study

Exclusion criteria

• Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol
• Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye)
• Extraocular/intraocular inflammation in either eye
• Clinically significant (WHO CTC Grade 1 or greater) liver function tests

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

527 participants in 2 patient groups, including a placebo group

Bromfenac

Experimental group

Description:

Topical bromfenac ophthalmic solution 0.1%

Treatment:

Drug: Bromfenac

Placebo

Placebo Comparator group

Description:

Vehicle of bromfenac

Treatment:

Drug: Placebo