Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

• Sponsor: Merck Sharp & Dohme Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00629941
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arm: 1
• Patients Per Site: 12.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Blepharitis	Drug: AzaSite®	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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%
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AzaSite®; Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days

Outcome Measures

Primary Outcome Measures

1. Change in clinical signs and symptoms associated with blepharitis [8 weeks]

Secondary Outcome Measures

1. Standard ocular safety assessments [4 weeks]

2. Change in tear cytokine and eyelid bacterial load levels [4 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Maine Eye Care	Lewiston	Maine	United States	04240
2	Ophthalmic Research Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• Merck Sharp & Dohme Corp.

Investigators

• Study Director: Reza Haque, MD, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00629941
• Other Study ID Numbers: 041-104; P08652
• First Posted: Mar 6, 2008
• Last Update Posted: Sep 26, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Blepharitis; Azithromycin

Study Results

No Results Posted as of Sep 26, 2011