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

Primary Purpose

Postoperative Complications, Cataract

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bromfenac
Placebo
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harold A Helms, MD
  • Eye Care Arkansas, PA
  • UCI, Department of Ophthalmology
  • Anesthetic Eye Care Institute
  • Richard A Lewis, MD
  • Eye Care of San Diego
  • Santa Clara Valley Medical Center
  • E Randy Craven, MD
  • The Eye Care Group
  • Cohen Laser Vision Center
  • Brandon Cataract Center & Eye Clinic
  • Marvin E Greenberg, MD, PA
  • Jack Daubert, MD
  • Advanced Eye Care, PC
  • Saltzer Medical Group, PA
  • Donald E Beahm, MD
  • Cincinnati Eye Institute NKY
  • Tulane University Health Sciences Center
  • Stevenson Medical Surgical Eye Center
  • Cornea Consultants
  • Great Lakes Eye Care
  • Hunkeler Eye Institute
  • Arthur J Weinstein, MD
  • Ophthalmic Consultants of Long Island
  • Horizon Eye Care
  • Dean A McGee Eye Institute
  • The Eye Institute
  • Casey Eye Institute
  • Eye Health Northwest
  • Scheie Eye Institute
  • Black Hills Regional Eye Institute
  • Middle Tennessee Eye Associates
  • Texan Eye Care PA
  • Ophthalmology Service, Brooke Army Medical Center
  • Ophthalmology Visual Science
  • Houston Eye Associates
  • David G Shulman, MD
  • Central Texas Eye Center
  • Virginia Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bromfenac

Placebo

Arm Description

Topical bromfenac ophthalmic solution 0.1%

Vehicle of bromfenac

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Ocular Inflammation Score
Mean change from baseline in SOIS at each visit.

Full Information

First Posted
September 12, 2005
Last Updated
March 13, 2013
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00198445
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Cataract
Keywords
Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
527 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bromfenac
Arm Type
Experimental
Arm Description
Topical bromfenac ophthalmic solution 0.1%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle of bromfenac
Intervention Type
Drug
Intervention Name(s)
Bromfenac
Intervention Description
One drop in study eye every 12 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One drop in study eye every 12 hours for 14 days
Primary Outcome Measure Information:
Title
Ocular Inflammation Score
Description
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
Time Frame
Visit 4 (Day 15)
Secondary Outcome Measure Information:
Title
Mean Ocular Inflammation Score
Description
Mean change from baseline in SOIS at each visit.
Time Frame
At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa R Grillone, PhD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Harold A Helms, MD
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Eye Care Arkansas, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UCI, Department of Ophthalmology
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Anesthetic Eye Care Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Richard A Lewis, MD
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Eye Care of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
E Randy Craven, MD
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
The Eye Care Group
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Cohen Laser Vision Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Brandon Cataract Center & Eye Clinic
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Marvin E Greenberg, MD, PA
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Jack Daubert, MD
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Advanced Eye Care, PC
City
Fort Oglethorpe
State/Province
Georgia
ZIP/Postal Code
30742
Country
United States
Facility Name
Saltzer Medical Group, PA
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Donald E Beahm, MD
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Cincinnati Eye Institute NKY
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Stevenson Medical Surgical Eye Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Cornea Consultants
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Great Lakes Eye Care
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Hunkeler Eye Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Arthur J Weinstein, MD
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Horizon Eye Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Dean A McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
The Eye Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Eye Health Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Middle Tennessee Eye Associates
City
Cookeville
State/Province
Tennessee
ZIP/Postal Code
38501
Country
United States
Facility Name
Texan Eye Care PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Ophthalmology Service, Brooke Army Medical Center
City
Ft. Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Ophthalmology Visual Science
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
David G Shulman, MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Central Texas Eye Center
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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