Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Phase 3

Completed

• Conditions: Pain; Inflammation
• Interventions: Drug: Placebo Comparator; Drug: Bromfenac Ophthalmic Solution

• Registration Number: NCT00853970
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Results First Submitted: 2010-11-15
• Disposition First Submitted: 2010-11-15
• Results First Submitted QC: 2011-01-07
• Disposition First Submitted QC: 2011-01-07
• Results First Posted: 2011-01-26
• Disposition First Posted: 2011-01-26
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

• Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria

• Have known hypersensitivity to bromfenac or to any component of the investigational product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparator	dosed 1 drop daily in study eye for 2 weeks
Bromfenac ophthalmic solution 0.09%	Bromfenac Ophthalmic Solution	dosed 1 drop daily in study eye for 2 weeks

Primary Outcome Measures

Name	Time	Method
Summed Ocular Inflammation Score (SOIS) of Zero	Day 15 (Primary Endpoint)	Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)

Secondary Outcome Measures

Name	Time	Method
Pain Free	Day 1	Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.

Trial Locations

Locations (1)

ISTA Pharmaceuticals, Inc.; 🇺🇸 Irvine, California, United States