Clinical trial NCT00105469: Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial Conjunctivitis
Pink Eye
Conjunctivitis
Eye Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-03-15
Enrollment: 743
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Achieved Clinical Resolution at Visit 3
timeFrame: Visit 3 (Day 6)
Secondary outcomes:
measure: Number of Participants Who Achieved Bacterial Eradication at Visit 3
timeFrame: Visit 3 (Day 6)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Renaissance Center
state: Alabama
city: Littleton
country: United States
facility: Children's Eye Physicians
state: Colorado
city: Atlantis
country: United States
facility: Palm Beach Eye Associates
state: Florida
city: Bradenton
country: United States
facility: The Eye Associates
state: Florida
city: Jupiter
country: United States
facility: Alan Shuster, MD
state: Florida
city: New Port Richey
country: United States
facility: Pasco Eye Institute
state: Florida
city: North Miami Beach
country: United States
facility: Tukoi Institute for Clinical Research
state: Florida
city: Panama City
country: United States
facility: Advanced Eye Care
state: Florida
city: West Palm Beach
country: United States
facility: Presidential Eye Center
state: Florida
city: Boise
country: United States
facility: Jon Fishburn, MD
state: Idaho
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic
state: Kansas
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Columbia
country: United States
facility: Mason Eye Institute
state: Missouri
city: Creve Coeur
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Kansas City
country: United States
facility: Research Eye Care Center
state: Missouri
city: Princeton
country: United States
facility: Ophthalmology Associates
state: New Jersey
city: Huntington Station
country: United States
facility: Huntington Medical Group
state: New York
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Portland
country: United States
facility: Eye Health Northwest
state: Oregon
city: Pittsburgh
country: United States
facility: Irving Weinberger, MD
state: Pennsylvania
city: Greenville
country: United States
facility: Southern Eye Associates, PA
state: South Carolina
city: El Paso
country: United States
facility: Corona Research Consultants, Inc.
state: Texas
city: Murray
country: United States
facility: Cottonwood Ophthalmology Associates
state: Utah
city: Spokane
country: United States
facility: Rockwood Clinic, PS-Eye Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
Study officials:
References:
citation: 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.