Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: placebo; Drug: bromfenac ophthalmic solution

• Registration Number: NCT00703781
• 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: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2008-11
• Results First Submitted: 2011-11-07
• Results First Submitted QC: 2011-11-07
• Results First Posted: 2011-12-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 ophthalmic solution	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 (trace); 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 taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop

Trial Locations

Locations (1)

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