Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva 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 Conjunctiva of Healthy Volunteers Following a Single Ocular Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564447
• Other study ID #: 041-102
• Secondary ID: P08654
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2007
• Last updated: September 20, 2011
• Start date: December 2007

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 at various time points in conjunctiva tissue of healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart

Exclusion Criteria:

• Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial

• Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)

• Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures

• Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies

• Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bacterial Infections
• Eye Infections
• Infection

Intervention

Drug:
• Azithromycin
azithromycin topical solution 1% given as a single drop in a single eye
• Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Pharmacokinetic Parameters		Up to 24 hours	No
Primary	Assessment of Pharmacokinetic Parameters	Conjunctiva Concentration of Azithromycin and Moxifloxacin	Over 24 hours	No