Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

InSite Vision

ClinicalTrials.gov Identifier:

NCT00578955

First received: December 19, 2007

Last updated: January 27, 2012

Last verified: January 2012

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 sodium phosphate Dexamethasone acetate Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

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 ]


Enrollment:	417
Study Start Date:	December 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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:	1 Year and older (Child, Adult, Senior)
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
Additional inclusion criteria also apply.

Exclusion Criteria:

Have known sensitivity or poor tolerance to any component of the study medications.
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.
Additional exclusion criteria also apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	InSite Vision
ClinicalTrials.gov Identifier:	NCT00578955 History of Changes
Other Study ID Numbers:	C-07-502-002
Study First Received:	December 19, 2007
Last Updated:	January 27, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

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 Antiemetics Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs 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 September 30, 2016

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