Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
Information source: Inspire Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections; Eye Infections; Cataract Extraction
Intervention: AzaSite (azithromycin ophthalmic solution) (Drug); Vigamox (moxifloxacin hydrochloride ophthalmic solution) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Inspire Pharmaceuticals Official(s) and/or principal investigator(s):
Reza Haque, MD, Study Director, Affiliation: Inspire Pharmaceuticals
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
Clinical Details
Official title: 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
Study design: Supportive Care, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Assessment of pharmacokinetic parameters
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Cornea Consultants of Arizone, Phoenix, Arizona 85032, United States
Eye Care Arkansas, Little Rock, Arkansas 72205, United States
North Valley Eye Medical Group, Mission Hills, California 91345, United States
Eye Center of North Florida, Panama City, Florida 32405, United States
Center for Excellence in Eye Care, Miami, Florida 33176, United States
Coastal Research Associates, LLC, Atlanta, Georgia 30339, United States
Kentuckiana Institute for Eye Research, Louisville, Kentucky 40207, United States
Ophthalmology Associates, St. Louis, Missouri 63131, United States
Ophthalmic Consultants of Long Island, Rockville Centre, New York 11563, United States
Eye Care Specialists, Kingston, Pennsylvania 18704, United States
Glaucoma Consultants and Center for Eye Research, Mount Pleasant, South Carolina 29464, United States
Medical University of South Carolina, Charleston, South Carolina 29464, United States
Corona Research Consultants, El Paso, Texas 79904, United States
Additional Information
Starting date: December 2007
Last updated: June 4, 2008
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