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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Conjunctivitis

Intervention: AzaSite (Drug); Vehicle (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Participants Who Achieved Clinical Resolution

Secondary outcome: Participants Who Achieved Bacteriological Eradication


Minimum age: 12 Months. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

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

Additional Information

Starting date: July 2004
Last updated: October 29, 2013

Page last updated: August 23, 2015

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