Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00575380

Purpose

The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery

Condition	Intervention	Phase
Bacterial Infections Eye Infections Cataract Extraction	Drug: AzaSite Eye Drops Drug: Vigamox Eye Drops	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	A Multi-Center, Open-Label, Randomized Study of the Pharmacokinetics of Azithromycin Versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Ophthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Cataract Eye Infections

Drug Information available for: Azithromycin Tetrahydrozoline Moxifloxacin Moxifloxacin hydrochloride Tetrahydrozoline hydrochloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) [ Time Frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 ] [ Designated as safety issue: No ]
Nominal time is scheduled time relative to administration of the first eye drop

Secondary Outcome Measures:

Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) [ Time Frame: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	December 2007
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: AzaSite Eye Drops One drop two times a day for two days and once a day for the next five days	Drug: AzaSite Eye Drops One drop two times a day for two days and once a day for the next five days. Other Name: AzaSite (azithromycin ophthalmic solution)
Active Comparator: Vigamox Eye Drops One drop three times a day for seven days	Drug: Vigamox Eye Drops One drop three times a day for seven days Other Name: Vigamox(moxifloxacin hydrochloride ophthalmic solution)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Are scheduled to undergo routine cataract surgery by the investigator's preferred technique.
Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.

Exclusion Criteria:

Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
Have a history of ocular pemphigoid.
Have ever had penetrating ocular surface surgery.
Have had intraocular surgery within the past 3 months.
Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site.
Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection.
Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery).
Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera.
Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study.
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.
Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis.
Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin.
Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance.
Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575380

Locations

United States, Arizona
Cornea Consultants of Arizone
Phoenix, Arizona, United States, 85032
United States, Arkansas
Eye Care Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
Eye Center of North Florida
Panama City, Florida, United States, 32405
United States, Georgia
Coastal Research Associates, LLC
Atlanta, Georgia, United States, 30339
United States, Kentucky
Kentuckiana Institute for Eye Research
Louisville, Kentucky, United States, 40207
United States, Missouri
Ophthalmology Associates
St. Louis, Missouri, United States, 63131
United States, New York
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11563
United States, Pennsylvania
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29464
Glaucoma Consultants and Center for Eye Research
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Corona Research Consultants
El Paso, Texas, United States, 79904

Sponsors and Collaborators

Merck

Investigators

Study Director:

Reza Haque, MD

Merck

More Information

No publications provided by Merck

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

Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. Epub 2010 Sep 1.

Responsible Party:	Mike Schiewe, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00575380 History of Changes
Other Study ID Numbers:	041-103, P08655
Study First Received:	December 12, 2007
Results First Received:	June 9, 2009
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Eye Infections
Cataract
Infection
Eye Diseases
Lens Diseases
Tetrahydrozoline
Azithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012