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

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); Tobramycin (Drug)

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 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.

Clinical Details

Official title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis

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

Primary outcome: Number of Participants Who Achieved Clinical Resolution at Visit 3

Secondary outcome: Number of Participants Who Achieved Bacterial Eradication at Visit 3


Minimum age: 1 Year. 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 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.

Locations and Contacts

Renaissance Center, Birmingham, Alabama 35205, United States

Children's Eye Physicians, Littleton, Colorado 80122, United States

Palm Beach Eye Associates, Atlantis, Florida 33462, United States

The Eye Associates, Bradenton, Florida 34209, United States

Alan Shuster, MD, Jupiter, Florida 33458, United States

Pasco Eye Institute, New Port Richey, Florida 34652, United States

Tukoi Institute for Clinical Research, North Miami Beach, Florida 33169, United States

Advanced Eye Care, Panama City, Florida 32405, United States

Presidential Eye Center, West Palm Beach, Florida 33401, United States

Jon Fishburn, MD, Boise, Idaho 83706, United States

Medisphere Medical Research Center, LLC, Evansville, Indiana 47714, United States

Hutchinson Clinic, Hutchinson, Kansas 67502, United States

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts 02114, United States

Mason Eye Institute, Columbia, Missouri 65212, United States

Ophthalmology Associates, Creve Coeur, Missouri 63141, United States

Research Eye Care Center, Kansas City, Missouri 64132, United States

Ophthalmology Associates, Princeton, New Jersey 08540, United States

Huntington Medical Group, Huntington Station, New York 11746, United States

Cornerstone Eye Care, High Point, North Carolina 27262, United States

Eye Health Northwest, Portland, Oregon 97209, United States

Irving Weinberger, MD, Pittsburgh, Pennsylvania 15228, United States

Southern Eye Associates, PA, Greenville, South Carolina 29605, United States

Corona Research Consultants, Inc., El Paso, Texas 79904, United States

Cottonwood Ophthalmology Associates, Murray, Utah 84107, United States

Rockwood Clinic, PS-Eye Center, Spokane, Washington 99205, United States

Wenatchee Valley Medical Center, Wenatchee, Washington 98801, United States

Additional Information

Starting date: July 2004
Last updated: November 21, 2013

Page last updated: August 23, 2015

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