Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis

Phase 4

Completed

• Conditions: Blepharitis
• Interventions: Drug: AzaSite®

• Registration Number: NCT00656539
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-07
• Study First Posted: 2008-04-11
• Primary Completion: 2008-11
• Disposition First Submitted: 2009-03-24
• Disposition First Submitted QC: 2009-05-04
• Disposition First Posted: 2009-11-17
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• diagnosis of moderate to severe chronic posterior blepharitis
• If female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria

• had ocular surface surgery (LASIK, refractive, pterygium) within the past year
• unwilling to discontinue use of contact lenses during the study
• have glaucoma
• unable or unwilling to withhold the use of eyelid scrubs during the study
• have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
• currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AzaSite®	AzaSite®

Primary Outcome Measures

Name	Time	Method
Change in clinical signs and symptoms associated with blepharitis	4 weeks

Secondary Outcome Measures

Name	Time	Method
Standard ocular safety assessments	4 weeks

Trial Locations

Locations (1)

Ophthalmic Consultants of Long Island; 🇺🇸 Lynbrook, New York, United States