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

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

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

Study Overview

• Status: Completed
• Conditions: Bacterial Infections; Eye Infections; Cataract Extraction
• Intervention / Treatment: Drug: AzaSite Eye Drops; Drug: Vigamox Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Vigamox(moxifloxacin hydrochloride ophthalmic solution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)	Nominal time is scheduled time relative to administration of the first eye drop	Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312

Secondary Outcome Measures

Outcome Measure	Time Frame
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)	Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.ajo.2010.05.039. Epub 2010 Sep 1.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 14, 2007
• First Posted (Estimate): December 18, 2007

Study Record Updates

• Last Update Posted (Estimate): September 22, 2011
• Last Update Submitted That Met QC Criteria: September 20, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Bacterial Infections and Mycoses; Lens Diseases; Infections; Communicable Diseases; Cataract; Bacterial Infections; Eye Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Pharmaceutical Solutions; Azithromycin
• Other Study ID Numbers: 041-103; P08655