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
2 other identifiers
interventional
743
1 country
26
Brief Summary
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.
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
Shorter than P25 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 14, 2005
CompletedFirst Posted
Study publicly available on registry
March 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedResults Posted
Study results publicly available
October 27, 2011
CompletedDecember 16, 2013
November 1, 2013
1.3 years
March 14, 2005
August 1, 2011
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Participants Who Achieved Bacterial Eradication at Visit 3
Visit 3 (Day 6)
Study Arms (2)
AzaSite
EXPERIMENTAL1.0% azithromycin in DuraSite
Tobramycin
ACTIVE COMPARATOR0.3% tobramycin
Interventions
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.
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.
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Renaissance Center
Birmingham, Alabama, 35205, United States
Children's Eye Physicians
Littleton, Colorado, 80122, United States
Palm Beach Eye Associates
Atlantis, Florida, 33462, United States
The Eye Associates
Bradenton, Florida, 34209, United States
Alan Shuster, MD
Jupiter, Florida, 33458, United States
Pasco Eye Institute
New Port Richey, Florida, 34652, United States
Tukoi Institute for Clinical Research
North Miami Beach, Florida, 33169, United States
Advanced Eye Care
Panama City, Florida, 32405, United States
Presidential Eye Center
West Palm Beach, Florida, 33401, United States
Jon Fishburn, MD
Boise, Idaho, 83706, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Hutchinson Clinic
Hutchinson, Kansas, 67502, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
Mason Eye Institute
Columbia, Missouri, 65212, United States
Ophthalmology Associates
Creve Coeur, Missouri, 63141, United States
Research Eye Care Center
Kansas City, Missouri, 64132, United States
Ophthalmology Associates
Princeton, New Jersey, 08540, United States
Huntington Medical Group
Huntington Station, New York, 11746, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
Eye Health Northwest
Portland, Oregon, 97209, United States
Irving Weinberger, MD
Pittsburgh, Pennsylvania, 15228, United States
Southern Eye Associates, PA
Greenville, South Carolina, 29605, United States
Corona Research Consultants, Inc.
El Paso, Texas, 79904, United States
Cottonwood Ophthalmology Associates
Murray, Utah, 84107, United States
Rockwood Clinic, PS-Eye Center
Spokane, Washington, 99205, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Related Publications (1)
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.
PMID: 17652708DERIVED
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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 14, 2005
First Posted
March 15, 2005
Study Start
July 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
December 16, 2013
Results First Posted
October 27, 2011
Record last verified: 2013-11