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

Completed · Phase 4

Conditions studied: Bacterial Infections, Eye Infections, Cataract Extraction

In brief

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

Key facts

Study ID

NCT00575380

Run by

Merck Sharp & Dohme LLC

People needed

116

Starts

2007-12-01

Last updated by the study team

2011-09-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cornea Consultants of Arizone — Phoenix, Arizona, 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
• Eye Center of North Florida — Panama City, Florida, United States
• Coastal Research Associates, LLC — Atlanta, Georgia, United States
• Kentuckiana Institute for Eye Research — Louisville, Kentucky, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Ophthalmic Consultants of Long Island — Rockville Centre, New York, United States
• Eye Care Specialists — Kingston, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Glaucoma Consultants and Center for Eye Research — Mt. Pleasant, South Carolina, United States
• Corona Research Consultants — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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