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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Azithromycin Dexamethasone Sodium Phosphate

U.S. FDA Resources

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

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

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Judith Hutcheson / Manager, Insite Vision Inc.
ClinicalTrials.gov Identifier:	NCT00754949 History of Changes
Other Study ID Numbers:	C-07-502-003
Study First Received:	September 16, 2008
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration; India: Drugs Controller General of India

Keywords provided by InSite Vision:

Blepharoconjunctivitis,
Ophthalmology

Additional relevant MeSH terms:

Conjunctivitis
Conjunctival Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Azithromycin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012