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

Phase 3

Completed

• Conditions: Postoperative Complications; Cataract
• Interventions: Drug: Placebo; Drug: Bromfenac

• Registration Number: NCT00198445
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Vehicle of bromfenac
Bromfenac	Bromfenac	Topical bromfenac ophthalmic solution 0.1%

Primary Outcome Measures

Name	Time	Method
Ocular Inflammation Score	Visit 4 (Day 15)	Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none

Secondary Outcome Measures

Name	Time	Method
Mean Ocular Inflammation Score	At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)	Mean change from baseline in SOIS at each visit.

Trial Locations

Locations (39)

Harold A Helms, MD; 🇺🇸 Birmingham, Alabama, United States

Eye Care Arkansas, PA; 🇺🇸 Little Rock, Arkansas, United States

UCI, Department of Ophthalmology; 🇺🇸 Irvine, California, United States

Anesthetic Eye Care Institute; 🇺🇸 Newport Beach, California, United States

Richard A Lewis, MD; 🇺🇸 Sacramento, California, United States

Eye Care of San Diego; 🇺🇸 San Diego, California, United States

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States

E Randy Craven, MD; 🇺🇸 Littleton, Colorado, United States

The Eye Care Group; 🇺🇸 New Haven, Connecticut, United States

Cohen Laser Vision Center; 🇺🇸 Boca Raton, Florida, United States

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