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

Phase 4

Completed

• Conditions: Bacterial Infections; Eye Infections; Cataract Extraction
• Interventions: Drug: Vigamox Eye Drops; Drug: AzaSite Eye Drops

• Registration Number: NCT00575380
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-18
• Primary Completion: 2008-06
• Results First Submitted: 2009-06-09
• Results First Submitted QC: 2009-08-11
• Results First Posted: 2009-09-16
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vigamox Eye Drops	Vigamox Eye Drops	One drop three times a day for seven days
AzaSite Eye Drops	AzaSite Eye Drops	One drop two times a day for two days and once a day for the next five days

Primary Outcome Measures

Name	Time	Method
Conjunctiva 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	Nominal time is scheduled time relative to administration of the first eye drop

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Eye Care Specialists; 🇺🇸 Kingston, Pennsylvania, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Rockville Centre, New York, United States

Ophthalmology Associates; 🇺🇸 St. Louis, Missouri, United States

Coastal Research Associates, LLC; 🇺🇸 Atlanta, Georgia, United States

Eye Center of North Florida; 🇺🇸 Panama City, Florida, United States

Kentuckiana Institute for Eye Research; 🇺🇸 Louisville, Kentucky, United States

Eye Care Arkansas; 🇺🇸 Little Rock, Arkansas, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Cornea Consultants of Arizone; 🇺🇸 Phoenix, Arizona, United States

Glaucoma Consultants and Center for Eye Research; 🇺🇸 Mount Pleasant, South Carolina, United States

Corona Research Consultants; 🇺🇸 El Paso, Texas, United States