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
2 other identifiers
interventional
685
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2004
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 15, 2005
CompletedFirst Posted
Study publicly available on registry
March 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedResults Posted
Study results publicly available
October 27, 2011
CompletedNovember 21, 2013
October 1, 2013
1.5 years
March 15, 2005
August 1, 2011
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Participants Who Achieved Bacteriological Eradication
Visit 3 (Day 6-7)
Study Arms (2)
AzaSite
EXPERIMENTALVehicle
SHAM COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
I Care! Eye Care!
Flagstaff, Arizona, 86001, United States
Rx For Life, Inc.
Cudahy, California, 90201, United States
North Bay Eye Associates
Petaluma and Santa Rosa, California, 95401, United States
San Diego Eye and Laser Center
San Diego, California, 92123, United States
Western States Clinical Research
Wheat Ridge, Colorado, 80033, United States
Opticare Eye Health Center
Waterbury, Connecticut, 06708, United States
International Eye Center
Tampa, Florida, 33603, United States
Welborn Clinic and Welborn Clinic East
Evansville, Indiana, 47713, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Bossier Optical Inc.
Bossier City, Louisiana, 71111, United States
Bohn and Joseph Eye Center
Lafayette, Louisiana, 70506, United States
The Louisiana Eye Center
Zachary, Louisiana, 70791, United States
Mississippi Eye Associates
Ocean Springs, Mississippi, 39564, United States
Clinical Research Laboratories
Piscataway, New Jersey, 08854, United States
Advanced Eyecare and Laser Center
Runnemede, New Jersey, 08078, United States
Precision Eye Care
Huntington, New York, 11743, United States
Charlotte Eye, Ear, Nose, and Throat
Charlotte, North Carolina, 28210, United States
Horizon Eye Center
Charlotte, North Carolina, 28211, United States
Groat Eyecare Associates
Greensboro, North Carolina, 27401, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
University Eye Surgeons
Maryville, Tennessee, 37803, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Eye Associates
Nashville, Tennessee, 37203, United States
Metaclin Research, Inc.
Austin, Texas, 78704, United States
Physicians Eye Associates & Cosmetic Laser
Houston, Texas, 77002, United States
Marc Sanders, MD
Houston, Texas, 77030, United States
Mark Mayo, MD
Pasadena, Texas, 77504, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Mountain View Eye Center
Layton, Utah, 84041, United States
Cottonwood Eye and Laser Clinic
Salt Lake City, Utah, 84107, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
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.
PMID: 18374301DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Late Stage Development Group Leader
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2005
First Posted
March 16, 2005
Study Start
July 1, 2004
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
November 21, 2013
Results First Posted
October 27, 2011
Record last verified: 2013-10