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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00105534

First received: March 15, 2005

Last updated: September 20, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 15, 2005
Last Updated Date	September 20, 2011
Start Date ^ICMJE	July 2004
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 20, 2011)	Participants Who Achieved Clinical Resolution [ Time Frame: Visit 3 (Days 6-7) ] [ Designated as safety issue: No ] Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Clinical assessments of ocular discharge Bacteriological cultures
Change History	Complete list of historical versions of study NCT00105534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 20, 2011)	Participants Who Achieved Bacteriological Eradication [ Time Frame: Visit 3 (Day 6-7) ] [ Designated as safety issue: No ] 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).
Original Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Adverse events Visual acuity Biomicroscopy Ophthalmoscopy
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Official Title ^ICMJE	A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Bacterial Conjunctivitis
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: AzaSite Intervention: Drug: AzaSite Sham Comparator: Vehicle Intervention: Other: Vehicle
Publications *	Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. Epub 2008 Mar 28.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	685
Completion Date	January 2006
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Months and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00105534
Other Study ID Numbers ^ICMJE	C-01-401-003, P08635
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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