Status:
COMPLETED
Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Postoperative Complications
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00198445
Start Date
May 1 2003
End Date
January 1 2004
Last Update
March 14 2013
Active Locations (39)
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1
Harold A Helms, MD
Birmingham, Alabama, United States, 35205
2
Eye Care Arkansas, PA
Little Rock, Arkansas, United States, 72205
3
UCI, Department of Ophthalmology
Irvine, California, United States, 92697
4
Anesthetic Eye Care Institute
Newport Beach, California, United States, 92663