Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution 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 tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 743
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Renaissance Center
  • Colorado
    • Littleton, Colorado, United States, 80122
      • Children's Eye Physicians
  • Florida
    • Atlantis, Florida, United States, 33462
      • Palm Beach Eye Associates
    • Bradenton, Florida, United States, 34209
      • The Eye Associates
    • Jupiter, Florida, United States, 33458
      • Alan Shuster, MD
    • New Port Richey, Florida, United States, 34652
      • Pasco Eye Institute
    • North Miami Beach, Florida, United States, 33169
      • Tukoi Institute for Clinical Research
    • Panama City, Florida, United States, 32405
      • Advanced Eye Care
    • West Palm Beach, Florida, United States, 33401
      • Presidential Eye Center
  • Idaho
    • Boise, Idaho, United States, 83706
      • Jon Fishburn, MD
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Hutchinson Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Mason Eye Institute
    • Creve Coeur, Missouri, United States, 63141
      • Ophthalmology Associates
    • Kansas City, Missouri, United States, 64132
      • Research Eye Care Center
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Ophthalmology Associates
  • New York
    • Huntington Station, New York, United States, 11746
      • Huntington Medical Group
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
  • Oregon
    • Portland, Oregon, United States, 97209
      • Eye Health Northwest
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15228
      • Irving Weinberger, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Southern Eye Associates, PA
  • Texas
    • El Paso, Texas, United States, 79904
      • Corona Research Consultants, Inc.
  • Utah
    • Murray, Utah, United States, 84107
      • Cottonwood Ophthalmology Associates
  • Washington
    • Spokane, Washington, United States, 99205
      • Rockwood Clinic, PS-Eye Center
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• 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 disease or 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 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
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AzaSite; 1.0% azithromycin in DuraSite	Drug: AzaSite; AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
ACTIVE_COMPARATOR: Tobramycin; 0.3% tobramycin	Drug: Tobramycin; Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Bacterial Eradication at Visit 3	Bacterial eradication is defined as 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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (ACTUAL): October 1, 2005
• Study Completion (ACTUAL): October 1, 2005

Study Registration Dates

• First Submitted: March 14, 2005
• First Submitted That Met QC Criteria: March 14, 2005
• First Posted (ESTIMATE): March 15, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): December 16, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Conjunctivitis; Eye Infection; Bacterial Conjunctivitis; Pink Eye
• 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; Tobramycin
• Other Study ID Numbers: P08633; C-01-401-004