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
Enrollment
39
Locations
2
Arms
8
Duration (Months)
13.5
Patients Per Site
1.7
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Harold A Helms, MDBirminghamAlabamaUnited States35205
2Eye Care Arkansas, PALittle RockArkansasUnited States72205
3UCI, Department of OphthalmologyIrvineCaliforniaUnited States92697
4Anesthetic Eye Care InstituteNewport BeachCaliforniaUnited States92663
5Richard A Lewis, MDSacramentoCaliforniaUnited States95819
6Eye Care of San DiegoSan DiegoCaliforniaUnited States92103
7Santa Clara Valley Medical CenterSan JoseCaliforniaUnited States95128
8E Randy Craven, MDLittletonColoradoUnited States80120
9The Eye Care GroupNew HavenConnecticutUnited States06510
10Cohen Laser Vision CenterBoca RatonFloridaUnited States33431
11Brandon Cataract Center & Eye ClinicBrandonFloridaUnited States33511
12Marvin E Greenberg, MD, PATamaracFloridaUnited States33321
13Jack Daubert, MDWest Palm BeachFloridaUnited States33401
14Advanced Eye Care, PCFort OglethorpeGeorgiaUnited States30742
15Saltzer Medical Group, PANampaIdahoUnited States83686
16Donald E Beahm, MDGreat BendKansasUnited States67530
17Cincinnati Eye Institute NKYEdgewoodKentuckyUnited States41017
18Tulane University Health Sciences CenterNew OrleansLouisianaUnited States70112
19Stevenson Medical Surgical Eye CenterNew OrleansLouisianaUnited States70119
20Cornea ConsultantsBostonMassachusettsUnited States02114
21Great Lakes Eye CareSt. JosephMichiganUnited States49085
22Hunkeler Eye InstituteKansas CityMissouriUnited States64111
23Arthur J Weinstein, MDAlbuquerqueNew MexicoUnited States87102
24Ophthalmic Consultants of Long IslandRockville CentreNew YorkUnited States11570
25Horizon Eye CareCharlotteNorth CarolinaUnited States28211
26Dean A McGee Eye InstituteOklahoma CityOklahomaUnited States73104
27The Eye InstituteTulsaOklahomaUnited States74104
28Casey Eye InstitutePortlandOregonUnited States97201
29Eye Health NorthwestPortlandOregonUnited States97209
30Scheie Eye InstitutePhiladelphiaPennsylvaniaUnited States19104
31Black Hills Regional Eye InstituteRapid CitySouth DakotaUnited States57701
32Middle Tennessee Eye AssociatesCookevilleTennesseeUnited States38501
33Texan Eye Care PAAustinTexasUnited States78705
34Ophthalmology Service, Brooke Army Medical CenterFt. Sam HoustonTexasUnited States78234
35Ophthalmology Visual ScienceGalvestonTexasUnited States77555
36Houston Eye AssociatesHoustonTexasUnited States77025
37David G Shulman, MDSan AntonioTexasUnited States78209
38Central Texas Eye CenterSan MarcosTexasUnited States78666
39Virginia Eye ConsultantsNorfolkVirginiaUnited States23507

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