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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00198445
Collaborator
(none)
527
39
2
8
13.5
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
527 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery
Study Start Date :
May 1, 2003
Actual Primary Completion Date :
Jan 1, 2004
Actual Study Completion Date :
Jan 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bromfenac

Topical bromfenac ophthalmic solution 0.1%

Drug: Bromfenac
One drop in study eye every 12 hours for 14 days

Placebo Comparator: Placebo

Vehicle of bromfenac

Drug: Placebo
One drop in study eye every 12 hours for 14 days

Outcome Measures

Primary Outcome Measures

  1. Ocular Inflammation Score [Visit 4 (Day 15)]

    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

  1. Mean Ocular Inflammation Score [At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)]

    Mean change from baseline in SOIS at each visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Richard A Lewis, MD Sacramento California United States 95819
6 Eye Care of San Diego San Diego California United States 92103
7 Santa Clara Valley Medical Center San Jose California United States 95128
8 E Randy Craven, MD Littleton Colorado United States 80120
9 The Eye Care Group New Haven Connecticut United States 06510
10 Cohen Laser Vision Center Boca Raton Florida United States 33431
11 Brandon Cataract Center & Eye Clinic Brandon Florida United States 33511
12 Marvin E Greenberg, MD, PA Tamarac Florida United States 33321
13 Jack Daubert, MD West Palm Beach Florida United States 33401
14 Advanced Eye Care, PC Fort Oglethorpe Georgia United States 30742
15 Saltzer Medical Group, PA Nampa Idaho United States 83686
16 Donald E Beahm, MD Great Bend Kansas United States 67530
17 Cincinnati Eye Institute NKY Edgewood Kentucky United States 41017
18 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
19 Stevenson Medical Surgical Eye Center New Orleans Louisiana United States 70119
20 Cornea Consultants Boston Massachusetts United States 02114
21 Great Lakes Eye Care St. Joseph Michigan United States 49085
22 Hunkeler Eye Institute Kansas City Missouri United States 64111
23 Arthur J Weinstein, MD Albuquerque New Mexico United States 87102
24 Ophthalmic Consultants of Long Island Rockville Centre New York United States 11570
25 Horizon Eye Care Charlotte North Carolina United States 28211
26 Dean A McGee Eye Institute Oklahoma City Oklahoma United States 73104
27 The Eye Institute Tulsa Oklahoma United States 74104
28 Casey Eye Institute Portland Oregon United States 97201
29 Eye Health Northwest Portland Oregon United States 97209
30 Scheie Eye Institute Philadelphia Pennsylvania United States 19104
31 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
32 Middle Tennessee Eye Associates Cookeville Tennessee United States 38501
33 Texan Eye Care PA Austin Texas United States 78705
34 Ophthalmology Service, Brooke Army Medical Center Ft. Sam Houston Texas United States 78234
35 Ophthalmology Visual Science Galveston Texas United States 77555
36 Houston Eye Associates Houston Texas United States 77025
37 David G Shulman, MD San Antonio Texas United States 78209
38 Central Texas Eye Center San Marcos Texas United States 78666
39 Virginia Eye Consultants Norfolk Virginia United States 23507

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198445
Other Study ID Numbers:
  • ISTA-BR-CS001
First Posted:
Sep 20, 2005
Last Update Posted:
Mar 14, 2013
Last Verified:
Mar 1, 2013
Keywords provided by Bausch & Lomb Incorporated
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2013