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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

InSite Vision

ClinicalTrials.gov Identifier:

NCT00754949

First received: September 16, 2008

Last updated: June 29, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 16, 2008
Last Updated Date	June 29, 2011
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 17, 2008)	Resolution of the clinical signs and symptoms. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00754949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 17, 2008)	Bacterial eradication [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Blepharoconjunctivitis
Intervention ^ICMJE	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 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 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
Study Arm (s)	Experimental: 1 Intervention: Drug: 1% Azithromycin and 0.1% Dexamethasone Active Comparator: 2 Intervention: Drug: 1% Azithromycin Active Comparator: 3 Intervention: Drug: 0.1% Dexamethasone
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	399
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00754949
Other Study ID Numbers ^ICMJE	C-07-502-003
Has Data Monitoring Committee	No
Responsible Party	Judith Hutcheson / Manager, Insite Vision Inc.
Study Sponsor ^ICMJE	InSite Vision
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	InSite Vision
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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