A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.

Official Title
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A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis

Conditions
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Blepharitis

Intervention / Treatment
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* Drug: Azithromycin ophthalmic solution, 1%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a current diagnosis of blepharitis Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 If female, are non-pregnant or non-lactating Exclusion Criteria: Have a concurrent acute hordeolum (stye) or chalazion Have inflammation of the ocular surface Have used artificial tears within 48 hours prior to Visit 1 or anticipate using during the study Have had ocular surgery in the past 90 days or will require it during the study Unable to withhold the use of contact lenses during the study Have a known hypersensitivity to azithromycin, erythromycin, any other macrolide antibiotic, or any of the other ingredients in the study medication Have been diagnosed with ongoing glaucoma Unable to withhold the use of ocular cosmetic products within 48 hours prior to Visit 1 and throughout the study Have a serious medical condition which could confound study assessments

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin ophthalmic solution, 1%<br> | Drug: Azithromycin ophthalmic solution, 1%<br>* 1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* 1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of clinical signs of blepharitis |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first clinical resolution |  | Days 7, 14, 21, 28, 42, 56, 70, and 84 | 
| Mean and change from baseline for clinical signs of blepharitis |  | Days 7, 14, 21, 28, 42, 56, 70, and 84 | 
| Mean and change from end of dosing for clinical signs of blepharitis |  | Days 42, 56, 70, and 84 | 
| Response to the Blepharitis Symptoms Questionnaire (BSQ) |  | Days 1, 7, 14, 21, 28, 42, 56, 70, and 84 |