Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Phase 4
Completed
- Conditions
- Bacterial InfectionsEye Infections
- Interventions
- 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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AzaSite AzaSite (azithromycin ophthalmic solution) - Vigamox Vigamox (moxifloxacin hydrochloride ophthalmic solution) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai School of Medicine
🇺🇸New York, New York, United States