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

Sponsored by:	InSite Vision
Information provided by:	InSite Vision
ClinicalTrials.gov Identifier:	NCT00754949

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

Drug Information available for: 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:

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:	399
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 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:	12 Years 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 6/24 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: NCT00754949

Contacts

Contact: Aron Shapiro

866-393-3767 ext 243

ashapiro@oraclinical.com

Sponsors and Collaborators

InSite Vision

More Information

Responsible Party:	Insite Vision Inc. ( Judith Hutcheson / Manager )
Study ID Numbers:	C-07-502-003
Study First Received:	September 16, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00754949
Health Authority:	United States: Food and Drug Administration; India: Drugs Controller General of India

Keywords provided by InSite Vision:

Blepharoconjunctivitis,
Ophthalmology

Study placed in the following topic categories:

Dexamethasone
Azithromycin
Eye Diseases

Conjunctivitis
Dexamethasone acetate
Conjunctival Diseases

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 January 13, 2009