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Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00629941
First received: February 27, 2008
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  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: 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:

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: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Standard ocular safety assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in tear cytokine and eyelid bacterial load levels [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

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
Other Name: AzaSite®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Reza Haque, MD Sponsor GmbH
  More Information

No publications provided

Responsible Party: Inspire Pharmaceuticals, Inc., sponsor
ClinicalTrials.gov Identifier: NCT00629941     History of Changes
Other Study ID Numbers: 041-104, P08652
Study First Received: February 27, 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 May 23, 2013