Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575367
• Other study ID #: 041-101
• Secondary ID: P08653
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2007
• Last updated: September 20, 2011
• Start date: March 2008

Study information

• 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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• 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.

Study Design

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

Related Conditions & MeSH terms

• Bacterial Infections
• Eye Infections
• Infection

Intervention

Drug:
• AzaSite (azithromycin ophthalmic solution)
One drop ophthalmic solution at Visit 2
• Vigamox (moxifloxacin hydrochloride ophthalmic solution)
One drop ophthalmic solution at Visit 2

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

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