Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Phase 3

Completed

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

• Registration Number: NCT01367249
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Disposition First Submitted: 2013-02-04
• Disposition First Submitted QC: 2013-02-04
• Disposition First Posted: 2013-02-06
• Status Verified: 2014-04
• Results First Submitted: 2014-04-04
• Results First Submitted QC: 2014-04-04
• Last Update Submitted: 2014-04-04
• Results First Posted: 2014-05-06
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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
Bromfenac Ophthalmic Solution	Bromfenac Ophthalmic Solution	Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Placebo	Placebo	One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.

Primary Outcome Measures

Name	Time	Method
Ocular Inflammation	Day 15	The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.

Secondary Outcome Measures

Name	Time	Method
Ocular Pain	Day 1	The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.

Trial Locations

Locations (1)

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