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Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections; Eye Infections

Intervention: AzaSite (azithromycin ophthalmic solution) (Drug); Vigamox (moxifloxacin hydrochloride ophthalmic solution) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Reza Haque, MD, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Mount Sinai School of Medicine, New York, New York 10029, United States
Additional Information

Starting date: March 2008
Last updated: September 20, 2011

Page last updated: August 23, 2015

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