Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis

This study has been completed.

First Received: March 15, 2005 Last Updated: March 12, 2007 History of Changes

Sponsor:	InSite Vision
Information provided by:	InSite Vision
ClinicalTrials.gov Identifier:	NCT00105534

Purpose

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.

Condition	Intervention	Phase
Bacterial Conjunctivitis	Drug: AzaSite	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Eye Infections Pinkeye

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by InSite Vision:

Primary Outcome Measures:

Clinical assessments of ocular discharge
Bacteriological cultures

Secondary Outcome Measures:

Adverse events
Visual acuity
Biomicroscopy
Ophthalmoscopy

Estimated Enrollment:	600
Study Start Date:	July 2004
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	12 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105534

Show 32 Study Locations

Sponsors and Collaborators

InSite Vision

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by InSite Vision

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	C-01-401-03
Study First Received:	March 15, 2005
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00105534 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by InSite Vision:

Bacterial Conjunctivitis
Pink Eye
Conjunctivitis
Eye Infection
Eye Discharge

Additional relevant MeSH terms:

Bacterial Infections
Eye Infections, Bacterial
Anti-Infective Agents
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Conjunctivitis

Infection
Conjunctival Diseases
Pharmacologic Actions
Anti-Bacterial Agents
Azithromycin
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2010