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

This study has been completed.

Sponsored by:	InSite Vision
Information provided by:	InSite Vision
ClinicalTrials.gov Identifier:	NCT00105469

Purpose

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.

Condition	Intervention	Phase
Bacterial Conjunctivitis	Drug: AzaSite	Phase III

MedlinePlus related topics: Eye Infections

Drug Information available for: Azithromycin Tobramycin Tobramycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active 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 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis

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:	800
Study Start Date:	July 2004
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	1 Year 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105469

Show 26 Study Locations

Sponsors and Collaborators

InSite Vision

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	C-01-401-004
Study First Received:	March 14, 2005
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00105469
Health Authority:	United States: Food and Drug Administration

Keywords provided by InSite Vision:

Bacterial Conjunctivitis
Pink Eye
Conjunctivitis
Eye Infection

Study placed in the following topic categories:

Bacterial Infections
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Tobramycin
Azithromycin

Eye Diseases
Eye Infections
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009