Clinical Trial: Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 AzaSi

Brief Summary: 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

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

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

Original Primary Outcome: Change in clinical signs and symptoms associated with blepharitis, tear cytokine and eyelid bacterial load levels [ Time Frame: 4 weeks ]

Current Secondary Outcome:

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


Original Secondary Outcome: Standard ocular safety assessments [ Time Frame: 4 weeks ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: February 27, 2008
Date Started: March 2008
Date Completion:
Last Updated: September 20, 2011
Last Verified: September 2011