Clinical trial NCT00198445: Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery
Official title: Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Complications
Cataract
Keywords: Cataract Extraction
Anti-Inflammatory Agents, Non-Steroidal
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Ocular Inflammation Score
timeFrame: Visit 4 (Day 15)
Secondary outcomes:
measure: Mean Ocular Inflammation Score
timeFrame: At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Harold A Helms, MD
state: Alabama
city: Little Rock
country: United States
facility: Eye Care Arkansas, PA
state: Arkansas
city: Irvine
country: United States
facility: UCI, Department of Ophthalmology
state: California
city: Newport Beach
country: United States
facility: Anesthetic Eye Care Institute
state: California
city: Sacramento
country: United States
facility: Richard A Lewis, MD
state: California
city: San Diego
country: United States
facility: Eye Care of San Diego
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Littleton
country: United States
facility: E Randy Craven, MD
state: Colorado
city: New Haven
country: United States
facility: The Eye Care Group
state: Connecticut
city: Boca Raton
country: United States
facility: Cohen Laser Vision Center
state: Florida
city: Brandon
country: United States
facility: Brandon Cataract Center & Eye Clinic
state: Florida
city: Tamarac
country: United States
facility: Marvin E Greenberg, MD, PA
state: Florida
city: West Palm Beach
country: United States
facility: Jack Daubert, MD
state: Florida
city: Fort Oglethorpe
country: United States
facility: Advanced Eye Care, PC
state: Georgia
city: Nampa
country: United States
facility: Saltzer Medical Group, PA
state: Idaho
city: Great Bend
country: United States
facility: Donald E Beahm, MD
state: Kansas
city: Edgewood
country: United States
facility: Cincinnati Eye Institute NKY
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Stevenson Medical Surgical Eye Center
state: Louisiana
city: Boston
country: United States
facility: Cornea Consultants
state: Massachusetts
city: St. Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Kansas City
country: United States
facility: Hunkeler Eye Institute
state: Missouri
city: Albuquerque
country: United States
facility: Arthur J Weinstein, MD
state: New Mexico
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Charlotte
country: United States
facility: Horizon Eye Care
state: North Carolina
city: Oklahoma City
country: United States
facility: Dean A McGee Eye Institute
state: Oklahoma
city: Tulsa
country: United States
facility: The Eye Institute
state: Oklahoma
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Portland
country: United States
facility: Eye Health Northwest
state: Oregon
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Cookeville
country: United States
facility: Middle Tennessee Eye Associates
state: Tennessee
city: Austin
country: United States
facility: Texan Eye Care PA
state: Texas
city: Ft. Sam Houston
country: United States
facility: Ophthalmology Service, Brooke Army Medical Center
state: Texas
city: Galveston
country: United States
facility: Ophthalmology Visual Science
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: David G Shulman, MD
state: Texas
city: San Marcos
country: United States
facility: Central Texas Eye Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Lisa R Grillone, PhD
role: STUDY_DIRECTOR
References: