Clinical trial NCT00575380: Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infections
Eye Infections
Cataract Extraction
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-12-18
Enrollment: 116
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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.

Primary outcomes:
measure: Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
timeFrame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Secondary outcomes:
measure: Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
timeFrame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea Consultants of Arizone
state: Arizona
city: Little Rock
country: United States
facility: Eye Care Arkansas
state: Arkansas
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Panama City
country: United States
facility: Eye Center of North Florida
state: Florida
city: Atlanta
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Louisville
country: United States
facility: Kentuckiana Institute for Eye Research
state: Kentucky
city: St. Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Glaucoma Consultants and Center for Eye Research
state: South Carolina
city: El Paso
country: United States
facility: Corona Research Consultants
state: Texas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Reza Haque, MD
role: STUDY_DIRECTOR
References:
citation: 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.