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

Study Overview
=================
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.

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

Conditions
-----------------
Bacterial Conjunctivitis

Intervention / Treatment
-----------------
* Drug: AzaSite
* Other: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AzaSite<br> | Drug: AzaSite<br>* 1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.<br>|
| Sham Comparator: Vehicle<br> | Other: Vehicle<br>* Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Achieved Clinical Resolution | Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. | Visit 3 (Days 6-7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Achieved Bacteriological Eradication | 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). | Visit 3 (Day 6-7) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection, Eye Discharge