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

This study has been completed.

First Received on February 21, 2008. Last Updated on September 20, 2011 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00629590

Purpose

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

Condition	Intervention	Phase
Blepharitis	Drug: AzaSite®	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single-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 for Two Weeks in Subjects With Posterior Blepharitis

Resource links provided by NLM:

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change in clinical signs and symptoms associated with blepharitis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Standard ocular safety assessments [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: AzaSite® ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days Other Name: AzaSite
No Intervention: 2

Eligibility

Criteria

Inclusion Criteria:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629590

Locations

United States, New York
South Shore Eye Care
Wantagh, New York, United States, 11793

Sponsors and Collaborators

Merck

Investigators

Study Director:

Reza Haque

works for Sponsor

More Information

No publications provided

Responsible Party:	Inspire Pharmaceuticals, Sponsor
ClinicalTrials.gov Identifier:	NCT00629590 History of Changes
Other Study ID Numbers:	041-106, P08649
Study First Received:	February 21, 2008
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Blepharitis
Eyelid Diseases
Eye Diseases
Azithromycin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012