Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

Phase 4

Completed

• Conditions: Bacterial Infections; Eye Infections
• Interventions: Drug: AzaSite (azithromycin ophthalmic solution); Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

• 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

Study Timeline

• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-18
• Study Start: 2008-03
• Primary Completion: 2008-10
• Results First Submitted: 2009-08-10
• Results First Submitted QC: 2009-08-11
• Results First Posted: 2009-09-17
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-22

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.

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.

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

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States