Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery

Official Title
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A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery

Conditions
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Bacterial Infections, Eye Infections, Cataract Extraction

Intervention / Treatment
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* Drug: AzaSite Eye Drops
* Drug: Vigamox Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are scheduled to undergo routine cataract surgery by the investigator's preferred technique. Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye. Exclusion Criteria: Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Have a history of ocular pemphigoid. Have ever had penetrating ocular surface surgery. Have had intraocular surgery within the past 3 months. Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site. Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection. Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery). Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera. Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study. 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. Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis. Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin. Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance. Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.

Ages Eligible for Study
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Minimum Age: 21 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 Eye Drops<br>One drop two times a day for two days and once a day for the next five days | Drug: AzaSite Eye Drops<br>* One drop two times a day for two days and once a day for the next five days.<br>* Other names: AzaSite (azithromycin ophthalmic solution);|
| Active Comparator: Vigamox Eye Drops<br>One drop three times a day for seven days | Drug: Vigamox Eye Drops<br>* One drop three times a day for seven days<br>* Other names: Vigamox(moxifloxacin hydrochloride ophthalmic solution);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Nominal time is scheduled time relative to administration of the first eye drop | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) |  | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 |