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.
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
I Care! Eye Care!, Flagstaff, Arizona 86001, United States
Rx For Life, Inc., Cudahy, California 90201, United States
North Bay Eye Associates, Petaluma and Santa Rosa, California 95401, United States
San Diego Eye and Laser Center, San Diego, California 92123, United States
Western States Clinical Research, Wheat Ridge, Colorado 80033, United States
Opticare Eye Health Center, Waterbury, Connecticut 06708, United States
International Eye Center, Tampa, Florida 33603, United States
Welborn Clinic and Welborn Clinic East, Evansville, Indiana 47713, United States
Taustine Eye Center, Louisville, Kentucky 40217, United States
Bossier Optical Inc., Bossier City, Louisiana 71111, United States
Bohn and Joseph Eye Center, Lafayette, Louisiana 70506, United States
The Louisiana Eye Center, Zachary, Louisiana 70791, United States
Mississippi Eye Associates, Ocean Springs, Mississippi 39564, United States
Clinical Research Laboratories, Piscataway, New Jersey 08854, United States
Advanced Eyecare and Laser Center, Runnemede, New Jersey 08078, United States
Precision Eye Care, Huntington, New York 11743, United States
Charlotte Eye, Ear, Nose, and Throat, Charlotte, North Carolina 28210, United States
Horizon Eye Center, Charlotte, North Carolina 28211, United States
Groat Eyecare Associates, Greensboro, North Carolina 27401, United States
Abrams Eye Center, Cleveland, Ohio 44115, United States
Bend Memorial Clinic, Bend, Oregon 97701, United States
University Eye Surgeons, Maryville, Tennessee 37803, United States
Total Eye Care, PA, Memphis, Tennessee 38119, United States
Eye Associates, Nashville, Tennessee 37203, United States
Metaclin Research, Inc., Austin, Texas 78704, United States
Marc Sanders, MD, Houston, Texas 77030, United States
Physicians Eye Associates & Cosmetic Laser, Houston, Texas 77002, United States
Mark Mayo, MD, Pasadena, Texas 77504, United States
Sun Research Institute, San Antonio, Texas 78205, United States
Mountain View Eye Center, Layton, Utah 84041, United States
Cottonwood Eye and Laser Clinic, Salt Lake City, Utah 84107, United States
Advanced Healthcare, SC, Milwaukee, Wisconsin 53209, United States
