Bacterial Conjunctivitis Clinical Trial
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
Verified date | November 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 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.
Status | Completed |
Enrollment | 743 |
Est. completion date | October 2005 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year 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 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Palm Beach Eye Associates | Atlantis | Florida |
United States | Renaissance Center | Birmingham | Alabama |
United States | Jon Fishburn, MD | Boise | Idaho |
United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
United States | The Eye Associates | Bradenton | Florida |
United States | Mason Eye Institute | Columbia | Missouri |
United States | Ophthalmology Associates | Creve Coeur | Missouri |
United States | Corona Research Consultants, Inc. | El Paso | Texas |
United States | Medisphere Medical Research Center, LLC | Evansville | Indiana |
United States | Southern Eye Associates, PA | Greenville | South Carolina |
United States | Cornerstone Eye Care | High Point | North Carolina |
United States | Huntington Medical Group | Huntington Station | New York |
United States | Hutchinson Clinic | Hutchinson | Kansas |
United States | Alan Shuster, MD | Jupiter | Florida |
United States | Research Eye Care Center | Kansas City | Missouri |
United States | Children's Eye Physicians | Littleton | Colorado |
United States | Cottonwood Ophthalmology Associates | Murray | Utah |
United States | Pasco Eye Institute | New Port Richey | Florida |
United States | Tukoi Institute for Clinical Research | North Miami Beach | Florida |
United States | Advanced Eye Care | Panama City | Florida |
United States | Irving Weinberger, MD | Pittsburgh | Pennsylvania |
United States | Eye Health Northwest | Portland | Oregon |
United States | Ophthalmology Associates | Princeton | New Jersey |
United States | Rockwood Clinic, PS-Eye Center | Spokane | Washington |
United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
United States | Presidential Eye Center | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Number of Participants Who Achieved Bacterial Eradication at Visit 3 | Bacterial eradication is defined as 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) | No |
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