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

Phase 3

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: AzaSite; Other: Vehicle

• Registration Number: NCT00105534
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-03-15
• Study First Submitted QC: 2005-03-15
• Study First Posted: 2005-03-16
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Results First Submitted: 2011-08-01
• Results First Submitted QC: 2011-09-20
• Results First Posted: 2011-10-27
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 685

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AzaSite	AzaSite	-
Vehicle	Vehicle	-

Primary Outcome Measures

Name	Time	Method
Participants Who Achieved Clinical Resolution	Visit 3 (Days 6-7)	Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.

Secondary Outcome Measures

Name	Time	Method
Participants Who Achieved Bacteriological Eradication	Visit 3 (Day 6-7)	Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).

Trial Locations

Locations (32)

I Care! Eye Care!; 🇺🇸 Flagstaff, Arizona, United States

Rx For Life, Inc.; 🇺🇸 Cudahy, California, United States

North Bay Eye Associates; 🇺🇸 Petaluma and Santa Rosa, California, United States

San Diego Eye and Laser Center; 🇺🇸 San Diego, California, United States

Western States Clinical Research; 🇺🇸 Wheat Ridge, Colorado, United States

Opticare Eye Health Center; 🇺🇸 Waterbury, Connecticut, United States

International Eye Center; 🇺🇸 Tampa, Florida, United States

Welborn Clinic and Welborn Clinic East; 🇺🇸 Evansville, Indiana, United States

Taustine Eye Center; 🇺🇸 Louisville, Kentucky, United States

Bossier Optical Inc.; 🇺🇸 Bossier City, Louisiana, United States

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