Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

Completed · Phase 3

Conditions studied: Bacterial Conjunctivitis

In brief

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.

Key facts

Study ID

NCT00105469

Run by

Merck Sharp & Dohme LLC

People needed

743

Starts

2004-07-01

Expected to finish

2005-10-01

Last updated by the study team

2013-12-16

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Renaissance Center — Birmingham, Alabama, United States
• Children's Eye Physicians — Littleton, Colorado, United States
• Palm Beach Eye Associates — Atlantis, Florida, United States
• The Eye Associates — Bradenton, Florida, United States
• Alan Shuster, MD — Jupiter, Florida, 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
• Presidential Eye Center — West Palm Beach, Florida, United States
• Jon Fishburn, MD — Boise, Idaho, United States
• Medisphere Medical Research Center, LLC — Evansville, Indiana, United States
• Hutchinson Clinic — Hutchinson, Kansas, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Mason Eye Institute — Columbia, Missouri, United States
• Ophthalmology Associates — Creve Coeur, Missouri, United States
• Research Eye Care Center — Kansas City, Missouri, United States
• Ophthalmology Associates — Princeton, New Jersey, United States
• Huntington Medical Group — Huntington Station, New York, United States
• Cornerstone Eye Care — High Point, North Carolina, United States
• Eye Health Northwest — Portland, Oregon, United States
• Irving Weinberger, MD — Pittsburgh, Pennsylvania, United States
• Southern Eye Associates, PA — Greenville, South Carolina, United States
• Corona Research Consultants, Inc. — El Paso, Texas, United States
• Cottonwood Ophthalmology Associates — Murray, Utah, United States
• Rockwood Clinic, PS-Eye Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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