Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

Official Title
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A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: AzaSite
* Drug: Tobramycin


Participation Criteria
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Eligibility Criteria
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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 disease or 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 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
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AzaSite<br>1.0% azithromycin in DuraSite | Drug: AzaSite<br>* AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.<br>|
| Active Comparator: Tobramycin<br>0.3% tobramycin | Drug: Tobramycin<br>* Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Bacterial Eradication at Visit 3 | Bacterial eradication is defined as 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) | 

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