Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)

A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

Study Overview

• Status: Completed
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: AzaSite; Other: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 685
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • I Care! Eye Care!
  • California
    • Cudahy, California, United States, 90201
      • Rx For Life, Inc.
    • Petaluma and Santa Rosa, California, United States, 95401
      • North Bay Eye Associates
    • San Diego, California, United States, 92123
      • San Diego Eye and Laser Center
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Opticare Eye Health Center
  • Florida
    • Tampa, Florida, United States, 33603
      • International Eye Center
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Welborn Clinic and Welborn Clinic East
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Bossier Optical Inc.
    • Lafayette, Louisiana, United States, 70506
      • Bohn and Joseph Eye Center
    • Zachary, Louisiana, United States, 70791
      • The Louisiana Eye Center
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Mississippi Eye Associates
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Clinical Research Laboratories
    • Runnemede, New Jersey, United States, 08078
      • Advanced Eyecare and Laser Center
  • New York
    • Huntington, New York, United States, 11743
      • Precision Eye Care
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye, Ear, Nose, and Throat
    • Charlotte, North Carolina, United States, 28211
      • Horizon Eye Center
    • Greensboro, North Carolina, United States, 27401
      • Groat Eyecare Associates
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Surgeons
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Nashville, Tennessee, United States, 37203
      • Eye Associates
  • Texas
    • Austin, Texas, United States, 78704
      • Metaclin Research, Inc.
    • Houston, Texas, United States, 77002
      • Physicians Eye Associates & Cosmetic Laser
    • Houston, Texas, United States, 77030
      • Marc Sanders, MD
    • Pasadena, Texas, United States, 77504
      • Mark Mayo, MD
    • San Antonio, Texas, United States, 78205
      • Sun Research Institute
  • Utah
    • Layton, Utah, United States, 84041
      • Mountain View Eye Center
    • Salt Lake City, Utah, United States, 84107
      • Cottonwood Eye and Laser Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Advanced Healthcare, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subject, of any race, who is at least 1 year of age.
• Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
• The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
• Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

• Any uncontrolled, systemic, debilitating disease.
• Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
• Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study.
• Any active upper respiratory tract infection.
• Pregnant or nursing females.
• Use of any antibiotic (topical or systemic) within 72 hours of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AzaSite	Drug: AzaSite; 1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
Sham Comparator: Vehicle	Other: Vehicle; Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Who Achieved Clinical Resolution	Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.	Visit 3 (Days 6-7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Who Achieved Bacteriological Eradication	Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).	Visit 3 (Day 6-7)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. doi: 10.1016/j.ajo.2008.01.019. Epub 2008 Mar 28.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: March 15, 2005
• First Submitted That Met QC Criteria: March 15, 2005
• First Posted (Estimate): March 16, 2005

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Conjunctivitis; Eye Infection; Bacterial Conjunctivitis; Pink Eye; Eye Discharge
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: P08635; C-01-401-003