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

Phase 3

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: Tobramycin; Drug: AzaSite

• Registration Number: NCT00105469
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-03-14
• Study First Submitted QC: 2005-03-14
• Study First Posted: 2005-03-15
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Results First Submitted: 2011-08-01
• Results First Submitted QC: 2011-09-20
• Results First Posted: 2011-10-27
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobramycin	Tobramycin	0.3% tobramycin
AzaSite	AzaSite	1.0% azithromycin in DuraSite

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Clinical Resolution at Visit 3	Visit 3 (Day 6)	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
Number of Participants Who Achieved Bacterial Eradication at Visit 3	Visit 3 (Day 6)	Bacterial eradication is defined as 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 (25)

Renaissance Center; 🇺🇸 Birmingham, Alabama, United States

Children's Eye Physicians; 🇺🇸 Littleton, Colorado, United States

Palm Beach Eye Associates; 🇺🇸 Atlantis, Florida, United States

The Eye Associates; 🇺🇸 Bradenton, Florida, United States

Alan Shuster, MD; 🇺🇸 Jupiter, Florida, United States

Pasco Eye Institute; 🇺🇸 New Port Richey, Florida, United States

Tukoi Institute for Clinical Research; 🇺🇸 North Miami Beach, Florida, United States

Advanced Eye Care; 🇺🇸 Panama City, Florida, United States

Presidential Eye Center; 🇺🇸 West Palm Beach, Florida, United States

Jon Fishburn, MD; 🇺🇸 Boise, Idaho, United States

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