Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

Blepharitis Clinical Trial

Official title:

A Multi-Center, Open-Label Study Evaluating the Cytokine and Eyelid Margin Bacterial Load Levels of Subjects Diagnosed With Chronic Blepharitis Following Dosing With AzaSite® (Azithromycin Ophthalmic Solution) 1%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629941
• Other study ID #: 041-104
• Secondary ID: P08652
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2008
• Last updated: September 20, 2011
• Start date: March 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 & symptoms of blepharitis and tear cytokine and eyelid bacterial load levels

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: August 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 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

Intervention Model: Single Group 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	Ophthalmic Research Associates	Andover	Massachusetts
United States	Central Maine Eye Care	Lewiston	Maine

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		8 weeks	No
Secondary	Standard ocular safety assessments		4 weeks	No
Secondary	Change in tear cytokine and eyelid bacterial load levels		4 Weeks	No