Study of AzaSite Versus Vigamox in the Tears 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 in tears 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 Tears of Healthy Volunteers Following a Single Ocular Administration

Conditions
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Bacterial Infections, Eye Infections

Intervention / Treatment
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* Drug: AzaSite (azithromycin ophthalmic solution)
* Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study. Have normal lid anatomy. Exclusion Criteria: Have an abnormal biomicroscopy or ophthalmoscopy exam. Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days. Have used artificial tears in the past thirty days. Have a diagnosis of on-going ocular infection or lid margin inflammation. Have ever had penetrating ocular surface or intraocular surgery. Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite. Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox. Have had corneal or lid abnormalities. Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes. Have any ocular pathology with the exception of cataracts. Have a serious systemic disease or uncontrolled medical condition. Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days. Have a history of liver or kidney disease resulting in persisting dysfunction.

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 |
| --- | --- |
| Active Comparator: AzaSite<br> | Drug: AzaSite (azithromycin ophthalmic solution)<br>* One drop ophthalmic solution at Visit 2<br>|
| Active Comparator: Vigamox<br> | Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)<br>* One drop ophthalmic solution at Visit 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. |  | 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours |