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

Bacterial Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105469
• Other study ID #: P08633
• Secondary ID: C-01-401-004
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2005
• Last updated: November 21, 2013
• Start date: July 2004
• Est. completion date: October 2005

Study information

• Verified date: November 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• AzaSite
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
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.

Locations

Country	Name	City	State
United States	Palm Beach Eye Associates	Atlantis	Florida
United States	Renaissance Center	Birmingham	Alabama
United States	Jon Fishburn, MD	Boise	Idaho
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	The Eye Associates	Bradenton	Florida
United States	Mason Eye Institute	Columbia	Missouri
United States	Ophthalmology Associates	Creve Coeur	Missouri
United States	Corona Research Consultants, Inc.	El Paso	Texas
United States	Medisphere Medical Research Center, LLC	Evansville	Indiana
United States	Southern Eye Associates, PA	Greenville	South Carolina
United States	Cornerstone Eye Care	High Point	North Carolina
United States	Huntington Medical Group	Huntington Station	New York
United States	Hutchinson Clinic	Hutchinson	Kansas
United States	Alan Shuster, MD	Jupiter	Florida
United States	Research Eye Care Center	Kansas City	Missouri
United States	Children's Eye Physicians	Littleton	Colorado
United States	Cottonwood Ophthalmology Associates	Murray	Utah
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	Irving Weinberger, MD	Pittsburgh	Pennsylvania
United States	Eye Health Northwest	Portland	Oregon
United States	Ophthalmology Associates	Princeton	New Jersey
United States	Rockwood Clinic, PS-Eye Center	Spokane	Washington
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Presidential Eye Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieved Clinical Resolution at Visit 3	Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).	Visit 3 (Day 6)	No
Secondary	Number of Participants Who Achieved Bacterial Eradication at Visit 3	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).	Visit 3 (Day 6)	No

External Links

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