Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00575380
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : September 16, 2009
Last Update Posted : September 22, 2011
Sponsor:
Information provided by:
Merck Sharp & Dohme LLC

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Bacterial Infections Eye Infections Cataract Extraction Drug: AzaSite Eye Drops Drug: Vigamox Eye Drops Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : December 2007
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: AzaSite Eye Drops
One drop two times a day for two days and once a day for the next five days
 Drug: AzaSite Eye Drops
One drop two times a day for two days and once a day for the next five days.
Other Name: AzaSite (azithromycin ophthalmic solution)
Active Comparator: Vigamox Eye Drops
One drop three times a day for seven days
 Drug: Vigamox Eye Drops
One drop three times a day for seven days
Other Name: Vigamox(moxifloxacin hydrochloride ophthalmic solution)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Conjunctiva 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 ]
    Nominal time is scheduled time relative to administration of the first eye drop


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575380


Locations
Layout table for location information
United States, Arizona
Cornea Consultants of Arizone
Phoenix, Arizona, United States, 85032
United States, Arkansas
Eye Care Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
Eye Center of North Florida
Panama City, Florida, United States, 32405
United States, Georgia
Coastal Research Associates, LLC
Atlanta, Georgia, United States, 30339
United States, Kentucky
Kentuckiana Institute for Eye Research
Louisville, Kentucky, United States, 40207
United States, Missouri
Ophthalmology Associates
St. Louis, Missouri, United States, 63131
United States, New York
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11563
United States, Pennsylvania
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29464
Glaucoma Consultants and Center for Eye Research
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Corona Research Consultants
El Paso, Texas, United States, 79904
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
Layout table for investigator information
Study Director: Reza Haque, MD Merck Sharp & Dohme LLC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Mike Schiewe, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00575380    
Other Study ID Numbers: 041-103
P08655
First Posted: December 18, 2007    Key Record Dates
Results First Posted: September 16, 2009
Last Update Posted: September 22, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Bacterial Infections
Eye Infections
Cataract
Disease Attributes
Pathologic Processes
Lens Diseases
Eye Diseases
Bacterial Infections and Mycoses
Azithromycin
Moxifloxacin
Pharmaceutical Solutions
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
 Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female