Bacterial Infections Clinical Trial
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
Verified date | September 2011 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
Status | Completed |
Enrollment | 37 |
Est. completion date | |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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