Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers - Full Text View

Sponsor:	Merck
Information provided by:	Merck
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: Azithromycin Drug: Moxifloxacin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
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 Merck:

Primary Outcome Measures:

Assessment of Pharmacokinetic Parameters [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
Assessment of Pharmacokinetic Parameters [ Time Frame: Over 24 hours ] [ Designated as safety issue: No ]
Conjunctiva Concentration of Azithromycin and Moxifloxacin

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

Arms	Assigned Interventions
Experimental: Azithromycin-30 minutes Post dose	Drug: Azithromycin azithromycin topical solution 1% given as a single drop in a single eye Other Name: AzaSite
Experimental: Azithromycin-2 hours post dose	Drug: Azithromycin azithromycin topical solution 1% given as a single drop in a single eye Other Name: AzaSite
Experimental: Azithromycin-12 hours post dose	Drug: Azithromycin azithromycin topical solution 1% given as a single drop in a single eye Other Name: AzaSite
Experimental: Azithromycin-24 hours post dose	Drug: Azithromycin azithromycin topical solution 1% given as a single drop in a single eye Other Name: AzaSite
Experimental: Moxifloxacin-30 minutes post dose	Drug: Moxifloxacin Moxifloxacin topical solution given as a single drop in a single eye Other Name: Vigamox
Experimental: Moxifloxacin-2 hours post dose	Drug: Moxifloxacin Moxifloxacin topical solution given as a single drop in a single eye Other Name: Vigamox
Experimental: Moxifloxacin-12 hours post dose	Drug: Moxifloxacin Moxifloxacin topical solution given as a single drop in a single eye Other Name: Vigamox
Experimental: Moxafloxacin-24 hours post dose	Drug: Moxifloxacin Moxifloxacin topical solution given as a single drop in a single eye Other Name: Vigamox

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

Merck

Investigators

Study Director:

Reza Haque

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Saiid Davari, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00564447 History of Changes
Other Study ID Numbers:	041-102, P08654
Study First Received:	November 20, 2007
Results First Received:	June 27, 2011
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Eye Infections
Infection
Eye Diseases
Azithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012