Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)

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 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.

Key facts

Study ID

NCT00105534

Run by

Merck Sharp & Dohme LLC

People needed

685

Starts

2004-07-01

Expected to finish

2006-01-01

Last updated by the study team

2013-11-21

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, 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

Where it is running

• I Care! Eye Care! — Flagstaff, Arizona, United States
• Rx For Life, Inc. — Cudahy, California, United States
• North Bay Eye Associates — Petaluma and Santa Rosa, California, United States
• San Diego Eye and Laser Center — San Diego, California, United States
• Western States Clinical Research — Wheat Ridge, Colorado, United States
• Opticare Eye Health Center — Waterbury, Connecticut, United States
• International Eye Center — Tampa, Florida, United States
• Welborn Clinic and Welborn Clinic East — Evansville, Indiana, United States
• Taustine Eye Center — Louisville, Kentucky, United States
• Bossier Optical Inc. — Bossier City, Louisiana, United States
• Bohn and Joseph Eye Center — Lafayette, Louisiana, United States
• The Louisiana Eye Center — Zachary, Louisiana, United States
• Mississippi Eye Associates — Ocean Springs, Mississippi, United States
• Clinical Research Laboratories — Piscataway, New Jersey, United States
• Advanced Eyecare and Laser Center — Runnemede, New Jersey, United States
• Precision Eye Care — Huntington, New York, United States
• Charlotte Eye, Ear, Nose, and Throat — Charlotte, North Carolina, United States
• Horizon Eye Center — Charlotte, North Carolina, United States
• Groat Eyecare Associates — Greensboro, North Carolina, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• Bend Memorial Clinic — Bend, Oregon, United States
• University Eye Surgeons — Maryville, Tennessee, United States
• Total Eye Care, PA — Memphis, Tennessee, United States
• Eye Associates — Nashville, Tennessee, United States
• Metaclin Research, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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