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Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

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: NCT00575367
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : September 17, 2009
Last Update Posted : September 22, 2011
Sponsor:
Information provided by:
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

Condition or disease Intervention/treatment Phase
Bacterial Infections Eye Infections Drug: AzaSite (azithromycin ophthalmic solution) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears of Healthy Volunteers Following a Single Ocular Administration
Study Start Date : March 2008
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AzaSite Drug: AzaSite (azithromycin ophthalmic solution)
One drop ophthalmic solution at Visit 2
Active Comparator: Vigamox Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop ophthalmic solution at Visit 2


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. [ Time Frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
  • Have normal lid anatomy.

Exclusion Criteria:

  • Have an abnormal biomicroscopy or ophthalmoscopy exam.
  • Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
  • Have used artificial tears in the past thirty days.
  • Have a diagnosis of on-going ocular infection or lid margin inflammation.
  • Have ever had penetrating ocular surface or intraocular surgery.
  • 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.
  • Have had corneal or lid abnormalities.
  • Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
  • Have any ocular pathology with the exception of cataracts.
  • Have a serious systemic disease or uncontrolled medical condition.
  • Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
  • Have a history of liver or kidney disease resulting in persisting dysfunction.
Contacts and Locations
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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): NCT00575367


Locations
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United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Reza Haque, MD Merck Sharp & Dohme LLC
More Information
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Responsible Party: Karen Kuhn, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00575367    
Other Study ID Numbers: 041-101
P08653
First Posted: December 18, 2007    Key Record Dates
Results First Posted: September 17, 2009
Last Update Posted: September 22, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Eye Infections
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Eye Diseases
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