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

Completed · Phase 3 · Has a placebo group

Conditions studied: Postoperative Complications, Cataract

In brief

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.

Key facts

Study ID

NCT00198445

Run by

Bausch & Lomb Incorporated

People needed

527

Starts

2003-05-01

Expected to finish

2004-01-01

Last updated by the study team

2013-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Brandon Cataract Center & Eye Clinic — Brandon, Florida, United States
• Marvin E Greenberg, MD, PA — Tamarac, Florida, United States
• Jack Daubert, MD — West Palm Beach, Florida, United States
• Advanced Eye Care, PC — Fort Oglethorpe, Georgia, United States
• Saltzer Medical Group, PA — Nampa, Idaho, United States
• Donald E Beahm, MD — Great Bend, Kansas, United States
• Cincinnati Eye Institute NKY — Edgewood, Kentucky, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Stevenson Medical Surgical Eye Center — New Orleans, Louisiana, United States
• Cornea Consultants — Boston, Massachusetts, United States
• Great Lakes Eye Care — Saint Joseph, Michigan, United States
• Hunkeler Eye Institute — Kansas City, Missouri, United States
• Arthur J Weinstein, MD — Albuquerque, New Mexico, United States
• Ophthalmic Consultants of Long Island — Rockville Centre, New York, United States
• Horizon Eye Care — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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