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

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

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.

Inclusion Criteria:

• Male or female subject, of any race, who is at least 1 year of age.
• Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
• The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
• Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

• Any uncontrolled, systemic, debilitating disease.
• Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
• Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study.
• Any active upper respiratory tract infection.
• Pregnant or nursing females.
• Use of any antibiotic (topical or systemic) within 72 hours of enrollment