- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105469
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
November 21, 2013 updated by: Merck Sharp & Dohme LLC
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
743
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- Renaissance Center
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Colorado
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Littleton, Colorado, United States, 80122
- Children's Eye Physicians
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Florida
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Atlantis, Florida, United States, 33462
- Palm Beach Eye Associates
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Bradenton, Florida, United States, 34209
- The Eye Associates
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Jupiter, Florida, United States, 33458
- Alan Shuster, MD
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New Port Richey, Florida, United States, 34652
- Pasco Eye Institute
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North Miami Beach, Florida, United States, 33169
- Tukoi Institute for Clinical Research
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Panama City, Florida, United States, 32405
- Advanced Eye Care
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West Palm Beach, Florida, United States, 33401
- Presidential Eye Center
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Idaho
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Boise, Idaho, United States, 83706
- Jon Fishburn, MD
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Indiana
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Evansville, Indiana, United States, 47714
- MediSphere Medical Research Center, LLC
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Kansas
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Hutchinson, Kansas, United States, 67502
- Hutchinson Clinic
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
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Missouri
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Columbia, Missouri, United States, 65212
- Mason Eye Institute
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Creve Coeur, Missouri, United States, 63141
- Ophthalmology Associates
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Kansas City, Missouri, United States, 64132
- Research Eye Care Center
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New Jersey
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Princeton, New Jersey, United States, 08540
- Ophthalmology Associates
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New York
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Huntington Station, New York, United States, 11746
- Huntington Medical Group
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North Carolina
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High Point, North Carolina, United States, 27262
- Cornerstone Eye Care
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Oregon
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Portland, Oregon, United States, 97209
- Eye Health Northwest
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15228
- Irving Weinberger, MD
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South Carolina
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Greenville, South Carolina, United States, 29605
- Southern Eye Associates, PA
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Texas
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El Paso, Texas, United States, 79904
- Corona Research Consultants, Inc.
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Utah
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Murray, Utah, United States, 84107
- Cottonwood Ophthalmology Associates
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Washington
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Spokane, Washington, United States, 99205
- Rockwood Clinic, PS-Eye Center
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Wenatchee, Washington, United States, 98801
- Wenatchee Valley Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AzaSite
1.0% azithromycin in DuraSite
|
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
|
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
Time Frame: Visit 3 (Day 6)
|
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
Time Frame: Visit 3 (Day 6)
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P08633
- C-01-401-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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