Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Phase 3

Completed

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

• Registration Number: NCT00586625
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

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: 2008-05
• Results First Submitted: 2009-10-08
• Results First Submitted QC: 2009-10-08
• Results First Posted: 2009-11-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 861

Inclusion Criteria

• Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria

• No active ocular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bepreve	Bepreve	bepotastine besilate ophthalmic solution 1.5%
Placebo	Placebo	vehicle

Primary Outcome Measures

Name	Time	Method
Ocular Comfort	Day 8 & Day 22	A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable