Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis

Phase 4

Completed

• Conditions: Blepharitis
• Interventions: Drug: AzaSite®

• Registration Number: NCT00629980
• 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: 2008-02
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Primary Completion: 2008-09
• 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: 60

Inclusion Criteria

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

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Exclusion Criteria

• had ocular surface surgery (LASIK, refractive, etc.) within the past year
• unwilling to discontinue the use of contact lenses during the study
• have glaucoma
• unable or unwilling to withhold the use of lid 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	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 (9)

Sall Research Medical Center; 🇺🇸 Artesia, California, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

South Shore Eye Care, LLP; 🇺🇸 Wantagh, New York, United States

Silverstein Eye Centers; 🇺🇸 Kansas City, Missouri, United States

Kentuckiana Institute for Eye Research; 🇺🇸 Louisville, Kentucky, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Corona Research Consultants, Inc.; 🇺🇸 El Paso, Texas, United States

Toyos Clinic; 🇺🇸 Jackson, Tennessee, United States