Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Completed · Phase 4
Conditions studied: Bacterial Infections, Eye Infections
In brief
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
Key facts
- Study ID
- NCT00575367
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 37
- Starts
- 2008-03-01
- Last updated by the study team
- 2011-09-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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