Bacterial Conjunctivitis Clinical Trial
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
Verified date | October 2013 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 685 |
Est. completion date | January 2006 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Months and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Metaclin Research, Inc. | Austin | Texas |
United States | Bend Memorial Clinic | Bend | Oregon |
United States | Bossier Optical Inc. | Bossier City | Louisiana |
United States | Charlotte Eye, Ear, Nose, and Throat | Charlotte | North Carolina |
United States | Horizon Eye Center | Charlotte | North Carolina |
United States | Abrams Eye Center | Cleveland | Ohio |
United States | Rx For Life, Inc. | Cudahy | California |
United States | Welborn Clinic and Welborn Clinic East | Evansville | Indiana |
United States | I Care! Eye Care! | Flagstaff | Arizona |
United States | Groat Eyecare Associates | Greensboro | North Carolina |
United States | Marc Sanders, MD | Houston | Texas |
United States | Physicians Eye Associates & Cosmetic Laser | Houston | Texas |
United States | Precision Eye Care | Huntington | New York |
United States | Bohn and Joseph Eye Center | Lafayette | Louisiana |
United States | Mountain View Eye Center | Layton | Utah |
United States | Taustine Eye Center | Louisville | Kentucky |
United States | University Eye Surgeons | Maryville | Tennessee |
United States | Total Eye Care, PA | Memphis | Tennessee |
United States | Advanced Healthcare, SC | Milwaukee | Wisconsin |
United States | Eye Associates | Nashville | Tennessee |
United States | Mississippi Eye Associates | Ocean Springs | Mississippi |
United States | Mark Mayo, MD | Pasadena | Texas |
United States | North Bay Eye Associates | Petaluma and Santa Rosa | California |
United States | Clinical Research Laboratories | Piscataway | New Jersey |
United States | Advanced Eyecare and Laser Center | Runnemede | New Jersey |
United States | Cottonwood Eye and Laser Clinic | Salt Lake City | Utah |
United States | Sun Research Institute | San Antonio | Texas |
United States | San Diego Eye and Laser Center | San Diego | California |
United States | International Eye Center | Tampa | Florida |
United States | Opticare Eye Health Center | Waterbury | Connecticut |
United States | Western States Clinical Research | Wheat Ridge | Colorado |
United States | The Louisiana Eye Center | Zachary | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Participants Who Achieved Bacteriological Eradication | Bacterial eradication is defined as the 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 6-7) | No |
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