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

Bacterial Conjunctivitis Clinical Trial

Official title:

A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105534
• Other study ID #: P08635
• Secondary ID: C-01-401-003
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2005
• Last updated: October 29, 2013
• Start date: July 2004
• Est. completion date: January 2006

Study information

• Verified date: October 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months 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, 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

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

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• AzaSite
1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

Other:
• Vehicle
Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

Locations

Country	Name	City	State
United States	Metaclin Research, Inc.	Austin	Texas
United States	Bend Memorial Clinic	Bend	Oregon
United States	Bossier Optical Inc.	Bossier City	Louisiana
United States	Charlotte Eye, Ear, Nose, and Throat	Charlotte	North Carolina
United States	Horizon Eye Center	Charlotte	North Carolina
United States	Abrams Eye Center	Cleveland	Ohio
United States	Rx For Life, Inc.	Cudahy	California
United States	Welborn Clinic and Welborn Clinic East	Evansville	Indiana
United States	I Care! Eye Care!	Flagstaff	Arizona
United States	Groat Eyecare Associates	Greensboro	North Carolina
United States	Marc Sanders, MD	Houston	Texas
United States	Physicians Eye Associates & Cosmetic Laser	Houston	Texas
United States	Precision Eye Care	Huntington	New York
United States	Bohn and Joseph Eye Center	Lafayette	Louisiana
United States	Mountain View Eye Center	Layton	Utah
United States	Taustine Eye Center	Louisville	Kentucky
United States	University Eye Surgeons	Maryville	Tennessee
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Advanced Healthcare, SC	Milwaukee	Wisconsin
United States	Eye Associates	Nashville	Tennessee
United States	Mississippi Eye Associates	Ocean Springs	Mississippi
United States	Mark Mayo, MD	Pasadena	Texas
United States	North Bay Eye Associates	Petaluma and Santa Rosa	California
United States	Clinical Research Laboratories	Piscataway	New Jersey
United States	Advanced Eyecare and Laser Center	Runnemede	New Jersey
United States	Cottonwood Eye and Laser Clinic	Salt Lake City	Utah
United States	Sun Research Institute	San Antonio	Texas
United States	San Diego Eye and Laser Center	San Diego	California
United States	International Eye Center	Tampa	Florida
United States	Opticare Eye Health Center	Waterbury	Connecticut
United States	Western States Clinical Research	Wheat Ridge	Colorado
United States	The Louisiana Eye Center	Zachary	Louisiana

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	Participants Who Achieved Clinical Resolution	Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.	Visit 3 (Days 6-7)	No
Secondary	Participants Who Achieved Bacteriological Eradication	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).	Visit 3 (Day 6-7)	No

External Links

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