Clinical trial NCT00105534: Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Official title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle 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
Eye Discharge
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-03-16
Enrollment: 685
Sex: ALL
Minimum age (years): 12
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 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.


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, 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

Primary outcomes:
measure: Participants Who Achieved Clinical Resolution
timeFrame: Visit 3 (Days 6-7)
Secondary outcomes:
measure: Participants Who Achieved Bacteriological Eradication
timeFrame: Visit 3 (Day 6-7)
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: I Care! Eye Care!
state: Arizona
city: Cudahy
country: United States
facility: Rx For Life, Inc.
state: California
city: Petaluma and Santa Rosa
country: United States
facility: North Bay Eye Associates
state: California
city: San Diego
country: United States
facility: San Diego Eye and Laser Center
state: California
city: Wheat Ridge
country: United States
facility: Western States Clinical Research
state: Colorado
city: Waterbury
country: United States
facility: Opticare Eye Health Center
state: Connecticut
city: Tampa
country: United States
facility: International Eye Center
state: Florida
city: Evansville
country: United States
facility: Welborn Clinic and Welborn Clinic East
state: Indiana
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Bossier City
country: United States
facility: Bossier Optical Inc.
state: Louisiana
city: Lafayette
country: United States
facility: Bohn and Joseph Eye Center
state: Louisiana
city: Zachary
country: United States
facility: The Louisiana Eye Center
state: Louisiana
city: Ocean Springs
country: United States
facility: Mississippi Eye Associates
state: Mississippi
city: Piscataway
country: United States
facility: Clinical Research Laboratories
state: New Jersey
city: Runnemede
country: United States
facility: Advanced Eyecare and Laser Center
state: New Jersey
city: Huntington
country: United States
facility: Precision Eye Care
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose, and Throat
state: North Carolina
city: Charlotte
country: United States
facility: Horizon Eye Center
state: North Carolina
city: Greensboro
country: United States
facility: Groat Eyecare Associates
state: North Carolina
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Maryville
country: United States
facility: University Eye Surgeons
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Nashville
country: United States
facility: Eye Associates
state: Tennessee
city: Austin
country: United States
facility: Metaclin Research, Inc.
state: Texas
city: Houston
country: United States
facility: Physicians Eye Associates & Cosmetic Laser
state: Texas
city: Houston
country: United States
facility: Marc Sanders, MD
state: Texas
city: Pasadena
country: United States
facility: Mark Mayo, MD
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Layton
country: United States
facility: Mountain View Eye Center
state: Utah
city: Salt Lake City
country: United States
facility: Cottonwood Eye and Laser Clinic
state: Utah
city: Milwaukee
country: United States
facility: Advanced Healthcare, SC
state: Wisconsin
Study officials:
References:
citation: 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.