Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
NCT ID: NCT00198445
Last Updated: 2013-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
527 participants
INTERVENTIONAL
2003-05-31
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bromfenac
Topical bromfenac ophthalmic solution 0.1%
Bromfenac
One drop in study eye every 12 hours for 14 days
Placebo
Vehicle of bromfenac
Placebo
One drop in study eye every 12 hours for 14 days
Interventions
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Bromfenac
One drop in study eye every 12 hours for 14 days
Placebo
One drop in study eye every 12 hours for 14 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa R Grillone, PhD
Role: STUDY_DIRECTOR
ISTA Pharmaceuticals, Inc.
Locations
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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
Dean A McGee Eye Institute
Oklahoma City, Oklahoma, United States
The Eye Institute
Tulsa, Oklahoma, United States
Casey Eye Institute
Portland, Oregon, United States
Eye Health Northwest
Portland, Oregon, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Middle Tennessee Eye Associates
Cookeville, Tennessee, United States
Texan Eye Care PA
Austin, Texas, United States
Ophthalmology Service, Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Ophthalmology Visual Science
Galveston, Texas, United States
Houston Eye Associates
Houston, Texas, United States
David G Shulman, MD
San Antonio, Texas, United States
Central Texas Eye Center
San Marcos, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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Other Identifiers
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ISTA-BR-CS001
Identifier Type: -
Identifier Source: org_study_id
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