Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers

Official Title
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A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Conjunctiva of Healthy Volunteers Following a Single Ocular Administration

Conditions
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Bacterial Infections, Eye Infections

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart Exclusion Criteria: Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders) Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin-30 minutes Post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-2 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-12 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Azithromycin-24 hours post dose<br> | Drug: Azithromycin<br>* azithromycin topical solution 1% given as a single drop in a single eye<br>* Other names: AzaSite;|
| Experimental: Moxifloxacin-30 minutes post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxifloxacin-2 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxifloxacin-12 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|
| Experimental: Moxafloxacin-24 hours post dose<br> | Drug: Moxifloxacin<br>* Moxifloxacin topical solution given as a single drop in a single eye<br>* Other names: Vigamox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pharmacokinetic Parameters |  | Up to 24 hours | 
| Assessment of Pharmacokinetic Parameters | Conjunctiva Concentration of Azithromycin and Moxifloxacin | Over 24 hours |