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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
116
One drop two times a day for two days and once a day for the next five days.
One drop three times a day for seven days
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
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
Time frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Time frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
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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
...and 3 more locations