MedPath

Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

Registration Number
NCT00575367
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
37
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AzaSiteAzaSite (azithromycin ophthalmic solution)-
VigamoxVigamox (moxifloxacin hydrochloride ophthalmic solution)-
Primary Outcome Measures
NameTimeMethod
Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mount Sinai School of Medicine

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath