Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
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
2 other identifiers
interventional
116
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 12, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedResults Posted
Study results publicly available
September 16, 2009
CompletedSeptember 22, 2011
September 1, 2011
6 months
December 12, 2007
June 9, 2009
September 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
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 (1)
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)
Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
Study Arms (2)
AzaSite Eye Drops
ACTIVE COMPARATOROne drop two times a day for two days and once a day for the next five days
Vigamox Eye Drops
ACTIVE COMPARATOROne drop three times a day for seven days
Interventions
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
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
Center for Excellence in Eye Care
Miami, Florida, 33176, United States
Eye Center of North Florida
Panama City, Florida, 32405, 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
Medical University of South Carolina
Charleston, South Carolina, 29464, United States
Glaucoma Consultants and Center for Eye Research
Mt. Pleasant, South Carolina, 29464, United States
Corona Research Consultants
El Paso, Texas, 79904, United States
Related Publications (1)
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.
PMID: 20813346DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mike Schiewe
- Organization
- Inspire
Study Officials
- STUDY DIRECTOR
Reza Haque, MD
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2007
First Posted
December 18, 2007
Study Start
December 1, 2007
Primary Completion
June 1, 2008
Last Updated
September 22, 2011
Results First Posted
September 16, 2009
Record last verified: 2011-09