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

This study has been completed.

First Received: November 20, 2007 Last Updated: May 8, 2009 History of Changes

Sponsor:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00564447

Purpose

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

Condition	Intervention	Phase
Bacterial Infections Eye Infections	Drug: AzaSite (azithromycin ophthalmic solution) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Eye Infections

Drug Information available for: Azithromycin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Assessment of pharmacokinetic parameters [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	Drug: AzaSite (azithromycin ophthalmic solution) One drop ophthalmic solution at Visit 2 (Day 0) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution) One drop ophthalmic solution at Visit 2 (Day 0)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564447

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Reza Haque

Inspire Pharmaceuticals

More Information

No publications provided by Inspire Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Inspire Pharmaceuticals, Inc. ( Saiid Davari )
Study ID Numbers:	041-102
Study First Received:	November 20, 2007
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00564447 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Moxifloxacin
Therapeutic Uses

Azithromycin
Eye Diseases
Eye Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010