Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Placebo; Drug: Bromfenac

• Registration Number: NCT00704418
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-24
• Primary Completion: 2009-01
• Study Completion: 2009-12
• Results First Submitted: 2010-11-15
• Results First Submitted QC: 2011-01-07
• Results First Posted: 2011-01-26
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Scheduled for cataract surgery

Exclusion Criteria

• Known hypersensitivity to bromfenac and salicylates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, dosed 1 drop daily
Bromfenac	Bromfenac	Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	Day 15	Participants with SOIS of 0. Scale: 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
Number of Participants That Are Pain Free	Day 1	Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses

Trial Locations

Locations (1)

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