Clinical Trial: Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)

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

Official Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

Brief Summary: The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Participants Who Achieved Clinical Resolution [ Time Frame: Visit 3 (Days 6-7) ]

Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.


Original Primary Outcome:

  • Clinical assessments of ocular discharge
  • Bacteriological cultures


Current Secondary Outcome: Participants Who Achieved Bacteriological Eradication [ Time Frame: Visit 3 (Day 6-7) ]

Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).


Original Secondary Outcome:

  • Adverse events
  • Visual acuity
  • Biomicroscopy
  • Ophthalmoscopy


Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: March 15, 2005
Date Started: July 2004
Date Completion:
Last Updated: October 29, 2013
Last Verified: October 2013