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

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.

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Key information

Conditions

Bacterial Conjunctivitis Bacterial Infections Bacterial Infections and Mycoses Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Eye Diseases Eye Infections Eye Infections, Bacterial Infections

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Renaissance Center, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AzaSite

Drug

AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.

Tobramycin

Drug

Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

Primary outcomes

Number of Participants Who Achieved Clinical Resolution at Visit 3

Time frame: 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 outcomes

Number of Participants Who Achieved Bacterial Eradication at Visit 3

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Mar 15, 2005
Registry last updated: Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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