Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis - Full Text View

Purpose

The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.

Condition	Intervention	Phase
Blepharoconjunctivitis	Drug: 1% Azithromycin and 0.1% Dexamethasone Drug: 1% Azithromycin Drug: 0.1% Dexamethasone	Phase III

ChemIDplus related topics:

Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Official Title:	A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis

Further study details as provided by InSite Vision:

Primary Outcome Measures:

The resolution of the clinical signs and symptoms. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bacterial eradication [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: 1% Azithromycin and 0.1% Dexamethasone Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
2: Active Comparator	Drug: 1% Azithromycin Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
3: Active Comparator	Drug: 0.1% Dexamethasone Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a clinical diagnosis of blepharoconjunctivitis
Must be willing to discontinue contact lens wear for the duration of the study
Have best corrected visual acuity of 20/100 in both eyes.
Have IOP less than or equal to 25 mmHg in either eye

Exclusion Criteria:

Have known sensitivity or poor tolerance to any component of the study medications.
Have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months.
Have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study.
Have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment.
Use of any eye make-up during the study.
Have any uncontrolled systemic disease or debilitating disease
Have been diagnosed with glaucoma
Have any clinically significant cardiovascular disorders
Have any history of liver or kidney disease resulting in persisting dysfunction
Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578955

Locations


United States, Massachusetts
	Ophthalmic Research Associates, Inc.
	North Andover, Massachusetts, United States, 01845

Sponsors and Collaborators

InSite Vision

More Information

Responsible Party:	Insite Vision Inc. ( Judith Hutcheson / Manager )
Study ID Numbers:	C-07-502-002
First Received:	December 19, 2007
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00578955
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by InSite Vision:

Blepharoconjunctivitis, Ophthalmology

Study placed in the following topic categories:

Dexamethasone

Azithromycin

Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Anti-Infective Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Glucocorticoids

Hormones

Pharmacologic Actions

Anti-Bacterial Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	InSite Vision
Information provided by:	InSite Vision
ClinicalTrials.gov Identifier:	NCT00578955