Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers - Full Text View

Sponsor:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00575367

Purpose

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears 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, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Eye Infections

Drug Information available for: Azithromycin Moxifloxacin Moxifloxacin hydrochloride

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. [ Time Frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	March 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575367

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Reza Haque, MD

Inspire Pharmaceuticals

More Information

No publications provided

Responsible Party:	Inspire Pharmaceuticals, Inc. ( Karen Kuhn )
Study ID Numbers:	041-101
Study First Received:	December 14, 2007
Results First Received:	August 10, 2009
Last Updated:	December 4, 2009
ClinicalTrials.gov Identifier:	NCT00575367 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