This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: February 27, 2008
Last updated: September 20, 2011
Last verified: September 2011
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:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00629941

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.
Study Director: Reza Haque, MD Sponsor GmbH
  More Information

Responsible Party: Inspire Pharmaceuticals, Inc., sponsor Identifier: NCT00629941     History of Changes
Other Study ID Numbers: 041-104
Study First Received: February 27, 2008
Last Updated: September 20, 2011

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions processed this record on August 16, 2017