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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Bacterial Conjunctivitis

Treatments

Drug: AzaSite

Other: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT00105534

C-01-401-003

P08635

Details and patient eligibility

About

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.

Enrollment

685 patients

Sex

All

Ages

12+ months old

Volunteers

No Healthy Volunteers

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