Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
- Conditions
- Postoperative ComplicationsCataract
- Interventions
- Drug: Placebo
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 527
- 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
- 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)
Eye Care of San Diego
🇺🇸San Diego, California, United States
Cornea Consultants
🇺🇸Boston, Massachusetts, United States
Ophthalmic Consultants of Long Island
🇺🇸Rockville Centre, New York, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Harold A Helms, MD
🇺🇸Birmingham, Alabama, United States
Dean A McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
David G Shulman, MD
🇺🇸San Antonio, Texas, United States
Eye Care Arkansas, PA
🇺🇸Little Rock, Arkansas, United States
Saltzer Medical Group, PA
🇺🇸Nampa, Idaho, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Middle Tennessee Eye Associates
🇺🇸Cookeville, Tennessee, United States
UCI, Department of Ophthalmology
🇺🇸Irvine, California, United States
Richard A Lewis, MD
🇺🇸Sacramento, California, United States
Anesthetic Eye Care Institute
🇺🇸Newport Beach, California, United States
Cohen Laser Vision Center
🇺🇸Boca Raton, Florida, United States
Santa Clara Valley Medical Center
🇺🇸San Jose, California, United States
E Randy Craven, MD
🇺🇸Littleton, Colorado, United States
Brandon Cataract Center & Eye Clinic
🇺🇸Brandon, Florida, United States
Jack Daubert, MD
🇺🇸West Palm Beach, Florida, United States
Marvin E Greenberg, MD, PA
🇺🇸Tamarac, Florida, United States
Advanced Eye Care, PC
🇺🇸Fort Oglethorpe, Georgia, United States
Donald E Beahm, MD
🇺🇸Great Bend, Kansas, United States
Cincinnati Eye Institute NKY
🇺🇸Edgewood, Kentucky, United States
Arthur J Weinstein, MD
🇺🇸Albuquerque, New Mexico, United States
Great Lakes Eye Care
🇺🇸St. Joseph, Michigan, United States
Horizon Eye Care
🇺🇸Charlotte, North Carolina, United States
The Eye Institute
🇺🇸Tulsa, Oklahoma, United States
Ophthalmology Service, Brooke Army Medical Center
🇺🇸Ft. Sam Houston, Texas, United States
Ophthalmology Visual Science
🇺🇸Galveston, Texas, United States
Central Texas Eye Center
🇺🇸San Marcos, Texas, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
The Eye Care Group
🇺🇸New Haven, Connecticut, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Stevenson Medical Surgical Eye Center
🇺🇸New Orleans, Louisiana, United States
Hunkeler Eye Institute
🇺🇸Kansas City, Missouri, United States
Casey Eye Institute
🇺🇸Portland, Oregon, United States
Eye Health Northwest
🇺🇸Portland, Oregon, United States
Texan Eye Care PA
🇺🇸Austin, Texas, United States