Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00564447

Recruitment Status : Completed

First Posted : November 28, 2007

Results First Posted : July 26, 2011

Last Update Posted : September 22, 2011

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

Merck Sharp & Dohme LLC

Tracking Information

First Submitted Date ^ICMJE

November 20, 2007

First Posted Date ^ICMJE

November 28, 2007

Results First Submitted Date ^ICMJE

June 27, 2011

Results First Posted Date ^ICMJE

July 26, 2011

Last Update Posted Date

September 22, 2011

Study Start Date ^ICMJE

December 2007

Actual Primary Completion Date

December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of Pharmacokinetic Parameters [ Time Frame: Up to 24 hours ]
Assessment of Pharmacokinetic Parameters [ Time Frame: Over 24 hours ]
Conjunctiva Concentration of Azithromycin and Moxifloxacin

Original Primary Outcome Measures ^ICMJE

Assessment of pharmacokinetic parameters [ Time Frame: Up to 24 hours ]

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

Official Title ^ICMJE

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

Brief 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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Condition ^ICMJE

Bacterial Infections
Eye Infections

Intervention ^ICMJE

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

Other Name: AzaSite
Drug: Moxifloxacin
Moxifloxacin topical solution given as a single drop in a single eye

Other Name: Vigamox

Study Arms ^ICMJE

Experimental: Azithromycin-30 minutes Post dose
Intervention: Drug: Azithromycin
Experimental: Azithromycin-2 hours post dose
Intervention: Drug: Azithromycin
Experimental: Azithromycin-12 hours post dose
Intervention: Drug: Azithromycin
Experimental: Azithromycin-24 hours post dose
Intervention: Drug: Azithromycin
Experimental: Moxifloxacin-30 minutes post dose
Intervention: Drug: Moxifloxacin
Experimental: Moxifloxacin-2 hours post dose
Intervention: Drug: Moxifloxacin
Experimental: Moxifloxacin-12 hours post dose
Intervention: Drug: Moxifloxacin
Experimental: Moxafloxacin-24 hours post dose
Intervention: Drug: Moxifloxacin

Publications *

Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14. doi: 10.1016/j.clinthera.2008.10.020.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

Not Provided

Actual Primary Completion Date

December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

United States

Administrative Information

NCT Number ^ICMJE

NCT00564447

Other Study ID Numbers ^ICMJE

041-102
P08654

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Saiid Davari, Inspire Pharmaceuticals, Inc.

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

Merck Sharp & Dohme LLC

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Reza Haque

Merck Sharp & Dohme LLC

PRS Account

Merck Sharp & Dohme LLC

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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