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

Cataract Clinical Trial

Official title:

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198445
• Other study ID #: ISTA-BR-CS001
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: March 13, 2013
• Start date: May 2003
• Est. completion date: January 2004

Study information

• Verified date: March 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Postoperative Complications

Intervention

Drug:
• Bromfenac
One drop in study eye every 12 hours for 14 days
• Placebo
One drop in study eye every 12 hours for 14 days

Locations

Country	Name	City	State
United States	Arthur J Weinstein, MD	Albuquerque	New Mexico
United States	Texan Eye Care PA	Austin	Texas
United States	Harold A Helms, MD	Birmingham	Alabama
United States	Cohen Laser Vision Center	Boca Raton	Florida
United States	Cornea Consultants	Boston	Massachusetts
United States	Brandon Cataract Center & Eye Clinic	Brandon	Florida
United States	Horizon Eye Care	Charlotte	North Carolina
United States	Middle Tennessee Eye Associates	Cookeville	Tennessee
United States	Cincinnati Eye Institute NKY	Edgewood	Kentucky
United States	Advanced Eye Care, PC	Fort Oglethorpe	Georgia
United States	Ophthalmology Service, Brooke Army Medical Center	Ft. Sam Houston	Texas
United States	Ophthalmology Visual Science	Galveston	Texas
United States	Donald E Beahm, MD	Great Bend	Kansas
United States	Houston Eye Associates	Houston	Texas
United States	UCI, Department of Ophthalmology	Irvine	California
United States	Hunkeler Eye Institute	Kansas City	Missouri
United States	Eye Care Arkansas, PA	Little Rock	Arkansas
United States	E Randy Craven, MD	Littleton	Colorado
United States	Saltzer Medical Group, PA	Nampa	Idaho
United States	The Eye Care Group	New Haven	Connecticut
United States	Stevenson Medical Surgical Eye Center	New Orleans	Louisiana
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Anesthetic Eye Care Institute	Newport Beach	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Dean A McGee Eye Institute	Oklahoma City	Oklahoma
United States	Scheie Eye Institute	Philadelphia	Pennsylvania
United States	Casey Eye Institute	Portland	Oregon
United States	Eye Health Northwest	Portland	Oregon
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Ophthalmic Consultants of Long Island	Rockville Centre	New York
United States	Richard A Lewis, MD	Sacramento	California
United States	David G Shulman, MD	San Antonio	Texas
United States	Eye Care of San Diego	San Diego	California
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Central Texas Eye Center	San Marcos	Texas
United States	Great Lakes Eye Care	St. Joseph	Michigan
United States	Marvin E Greenberg, MD, PA	Tamarac	Florida
United States	The Eye Institute	Tulsa	Oklahoma
United States	Jack Daubert, MD	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Inflammation Score	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	Visit 4 (Day 15)	No
Secondary	Mean Ocular Inflammation Score	Mean change from baseline in SOIS at each visit.	At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)	No