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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00578955

First Posted: December 21, 2007

Last Update Posted: January 31, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

InSite Vision

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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 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 ]

Secondary Outcome Measures:

Bacterial eradication [ Time Frame: 2 weeks ]


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	1 Year and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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
First Submitted:	December 19, 2007
First Posted:	December 21, 2007
Last Update Posted:	January 31, 2012
Last Verified:	January 2012

Keywords provided by InSite Vision:


Blepharoconjunctivitis, Ophthalmology

Additional relevant MeSH terms:


Conjunctivitis Conjunctival Diseases Eye Diseases Dexamethasone acetate Dexamethasone 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

To Top