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

This study is ongoing, but not recruiting participants.

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00629980

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

Drug Information available for: Azithromycin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

change in clinical signs and symptoms associated with blepharitis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

standard ocular safety assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AzaSite® ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
2: No Intervention

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629980

Locations

United States, California
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
Sall Research Medical Center
Artesia, California, United States, 90701
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Kentucky
Kentuckiana Institute for Eye Research
Louisville, Kentucky, United States, 40207
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
United States, New York
South Shore Eye Care, LLP
Wantagh, New York, United States, 11793
United States, Tennessee
Toyos Clinic
Jackson, Tennessee, United States, 38301
United States, Texas
Corona Research Consultants, Inc.
El Paso, Texas, United States, 79904

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Reza Haque, MD

Sponsor GmbH

More Information

Responsible Party:	Inspire Pharmaceuticals, Inc ( Mike Schiewe )
Study ID Numbers:	041-105
Study First Received:	February 27, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00629980
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Azithromycin
Eye Diseases
Blepharitis

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009