Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Placebo; Drug: Bromfenac

• Registration Number: NCT00423007
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-15
• Study First Submitted QC: 2007-01-15
• Study First Posted: 2007-01-17
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• History of clinically active allergic conjunctivitis
• Agree to return for all required visits
• Agree to avoid disallowed meds

Exclusion Criteria

• Known hypersensitivity to bromfenac and salicylates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Vehicle ophthalmic solution
Bromfenac	Bromfenac	Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Treatment of ocular itching

Secondary Outcome Measures

Name	Time	Method
Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing

Trial Locations

Locations (1)

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