Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery
1 other identifier
interventional
527
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
Shorter than P25 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedMarch 14, 2013
March 1, 2013
8 months
September 12, 2005
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
Mean Ocular Inflammation Score
At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)
Study Arms (2)
Bromfenac
EXPERIMENTALTopical bromfenac ophthalmic solution 0.1%
Placebo
PLACEBO COMPARATORVehicle of bromfenac
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Harold A Helms, MD
Birmingham, Alabama, 35205, United States
Eye Care Arkansas, PA
Little Rock, Arkansas, 72205, United States
UCI, Department of Ophthalmology
Irvine, California, 92697, United States
Anesthetic Eye Care Institute
Newport Beach, California, 92663, United States
Richard A Lewis, MD
Sacramento, California, 95819, United States
Eye Care of San Diego
San Diego, California, 92103, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
E Randy Craven, MD
Littleton, Colorado, 80120, United States
The Eye Care Group
New Haven, Connecticut, 06510, United States
Cohen Laser Vision Center
Boca Raton, Florida, 33431, United States
Brandon Cataract Center & Eye Clinic
Brandon, Florida, 33511, United States
Marvin E Greenberg, MD, PA
Tamarac, Florida, 33321, United States
Jack Daubert, MD
West Palm Beach, Florida, 33401, United States
Advanced Eye Care, PC
Fort Oglethorpe, Georgia, 30742, United States
Saltzer Medical Group, PA
Nampa, Idaho, 83686, United States
Donald E Beahm, MD
Great Bend, Kansas, 67530, United States
Cincinnati Eye Institute NKY
Edgewood, Kentucky, 41017, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Stevenson Medical Surgical Eye Center
New Orleans, Louisiana, 70119, United States
Cornea Consultants
Boston, Massachusetts, 02114, United States
Great Lakes Eye Care
Saint Joseph, Michigan, 49085, United States
Hunkeler Eye Institute
Kansas City, Missouri, 64111, United States
Arthur J Weinstein, MD
Albuquerque, New Mexico, 87102, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570, United States
Horizon Eye Care
Charlotte, North Carolina, 28211, United States
Dean A McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
The Eye Institute
Tulsa, Oklahoma, 74104, United States
Casey Eye Institute
Portland, Oregon, 97201, United States
Eye Health Northwest
Portland, Oregon, 97209, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Middle Tennessee Eye Associates
Cookeville, Tennessee, 38501, United States
Texan Eye Care PA
Austin, Texas, 78705, United States
Ophthalmology Service, Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Ophthalmology Visual Science
Galveston, Texas, 77555, United States
Houston Eye Associates
Houston, Texas, 77025, United States
David G Shulman, MD
San Antonio, Texas, 78209, United States
Central Texas Eye Center
San Marcos, Texas, 78666, United States
Virginia Eye Consultants
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa R Grillone, PhD
ISTA Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
May 1, 2003
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
March 14, 2013
Record last verified: 2013-03