Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

Study Overview
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Brief Summary
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The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.

Official Title
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A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis

Conditions
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Blepharoconjunctivitis

Intervention / Treatment
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* Drug: 1% Azithromycin and 0.1% Dexamethasone
* Drug: 1% Azithromycin
* Drug: 0.1% Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a clinical diagnosis of blepharoconjunctivitis Must be willing to discontinue contact lens wear for the duration of the study Have best corrected visual acuity of 6/24 in both eyes Have IOP less than or equal to 25 mmHg in either eye Exclusion Criteria: Have known sensitivity or poor tolerance to any component of the study medications Have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months Have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study Have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment Use of any eye make-up during the study Have any uncontrolled systemic disease or debilitating disease Have been diagnosed with glaucoma Have any clinically significant cardiovascular disorders Have any history of liver or kidney disease resulting in persisting dysfunction Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device

Ages Eligible for Study
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Minimum Age: 12 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: 1<br> | Drug: 1% Azithromycin and 0.1% Dexamethasone<br>* Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.<br>* Other names: AzaSite Plus;|
| Active Comparator: 2<br> | Drug: 1% Azithromycin<br>* Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.<br>* Other names: AzaSite;|
| Active Comparator: 3<br> | Drug: 0.1% Dexamethasone<br>* Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of the clinical signs and symptoms. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial eradication |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharoconjunctivitis,, Ophthalmology