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

Blepharitis Clinical Trial

Official title:

A Multi-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone in Subjects With Blepharitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629980
• Other study ID #: 041-105
• Secondary ID: P08651
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2008
• Last updated: September 20, 2011
• Start date: February 2008

Study information

• Verified date: September 2011
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of moderate to severe chronic blepharitis

• if female of childbearing potential, are non-pregnant and non-lactating

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• AzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days

Locations

Country	Name	City	State
United States	Sall Research Medical Center	Artesia	California
United States	Corona Research Consultants, Inc.	El Paso	Texas
United States	Toyos Clinic	Jackson	Tennessee
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Tauber Eye Center	Kansas City	Missouri
United States	Kentuckiana Institute for Eye Research	Louisville	Kentucky
United States	Center for Excellence in Eye Care	Miami	Florida
United States	North Valley Eye Medical Group	Mission Hills	California
United States	South Shore Eye Care, LLP	Wantagh	New York

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in clinical signs and symptoms associated with blepharitis		4 weeks	No
Secondary	standard ocular safety assessments		4 weeks	No