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

PHASE3CompletedINTERVENTIONAL
Enrollment

685

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

January 31, 2006

Study Completion Date

January 31, 2006

Conditions
Bacterial Conjunctivitis
Interventions
DRUG

AzaSite

"1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected~eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days."

OTHER

Vehicle

Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

Trial Locations (32)

11743

Precision Eye Care, Huntington

27401

Groat Eyecare Associates, Greensboro

28210

Charlotte Eye, Ear, Nose, and Throat, Charlotte

28211

Horizon Eye Center, Charlotte

33603

International Eye Center, Tampa

37203

Eye Associates, Nashville

37803

University Eye Surgeons, Maryville

38119

Total Eye Care, PA, Memphis

39564

Mississippi Eye Associates, Ocean Springs

40217

Taustine Eye Center, Louisville

44115

Abrams Eye Center, Cleveland

47713

Welborn Clinic and Welborn Clinic East, Evansville

53209

Advanced Healthcare, SC, Milwaukee

70506

Bohn and Joseph Eye Center, Lafayette

70791

The Louisiana Eye Center, Zachary

71111

Bossier Optical Inc., Bossier City

77002

Physicians Eye Associates & Cosmetic Laser, Houston

77030

Marc Sanders, MD, Houston

77504

Mark Mayo, MD, Pasadena

78205

Sun Research Institute, San Antonio

78704

Metaclin Research, Inc., Austin

80033

Western States Clinical Research, Wheat Ridge

84041

Mountain View Eye Center, Layton

84107

Cottonwood Eye and Laser Clinic, Salt Lake City

86001

I Care! Eye Care!, Flagstaff

90201

Rx For Life, Inc., Cudahy

92123

San Diego Eye and Laser Center, San Diego

95401

North Bay Eye Associates, Petaluma and Santa Rosa

97701

Bend Memorial Clinic, Bend

06708

Opticare Eye Health Center, Waterbury

08854

Clinical Research Laboratories, Piscataway

08078

Advanced Eyecare and Laser Center, Runnemede

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00105534 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) | Biotech Hunter | Biotech Hunter