Efficacy and Safety of Bromfenac Ophthalmic Solution

Phase 2

Completed

• Conditions: Cataract Surgery
• Interventions: Drug: bromfenac ophthalmic solution

• Registration Number: NCT00585975
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

This is a safety and efficacy study of bromfenac ophthalmic solution

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Primary Completion: 2008-07
• Results First Submitted: 2011-11-07
• Results First Submitted QC: 2011-11-07
• Results First Posted: 2011-12-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 568

Inclusion Criteria

• Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion Criteria

• Active corneal pathology in either eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xibrom 0.09%	bromfenac ophthalmic solution	-
Bromfenac Ophthalmic Solution 0.18%	bromfenac ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero	Day 15	Participants with SOIS of 1. 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

Trial Locations

Locations (1)

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