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Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629941
First Posted: March 6, 2008
Last Update Posted: September 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck Sharp & Dohme Corp.
  Purpose
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 Intervention Phase
Blepharitis Drug: AzaSite® Phase 4

Study Type: Interventional
Study Design: 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%

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in clinical signs and symptoms associated with blepharitis [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Standard ocular safety assessments [ Time Frame: 4 weeks ]
  • Change in tear cytokine and eyelid bacterial load levels [ Time Frame: 4 Weeks ]

Estimated Enrollment: 25
Study Start Date: March 2008
Primary Completion Date: August 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 ~26 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629941


Locations
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Reza Haque, MD Sponsor GmbH
  More Information

Responsible Party: Inspire Pharmaceuticals, Inc., sponsor
ClinicalTrials.gov Identifier: NCT00629941     History of Changes
Other Study ID Numbers: 041-104
P08652
First Submitted: February 27, 2008
First Posted: March 6, 2008
Last Update Posted: September 26, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions