Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00575367
First received: December 14, 2007
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: March 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575367

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Reza Haque, MD Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Karen Kuhn, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00575367     History of Changes
Other Study ID Numbers: 041-101, P08653
Study First Received: December 14, 2007
Results First Received: August 10, 2009
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Infection
Eye Diseases
Azithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014