Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
NCT ID: NCT00575380
Last Updated: 2011-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
116 participants
INTERVENTIONAL
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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AzaSite Eye Drops
One drop two times a day for two days and once a day for the next five days
AzaSite Eye Drops
One drop two times a day for two days and once a day for the next five days.
Vigamox Eye Drops
One drop three times a day for seven days
Vigamox Eye Drops
One drop three times a day for seven days
Interventions
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AzaSite Eye Drops
One drop two times a day for two days and once a day for the next five days.
Vigamox Eye Drops
One drop three times a day for seven days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.
Exclusion Criteria
* 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.
21 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Inspire Pharmaceuticals
Principal Investigators
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Reza Haque, MD
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Countries
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References
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Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. doi: 10.1016/j.ajo.2010.05.039. Epub 2010 Sep 1.
Other Identifiers
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P08655
Identifier Type: -
Identifier Source: secondary_id
041-103
Identifier Type: -
Identifier Source: org_study_id