Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis (DOUBle)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

InSite Vision

ClinicalTrials.gov Identifier:

NCT01408082

First received: August 1, 2011

Last updated: September 13, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 1, 2011
Last Updated Date	September 13, 2012
Start Date ^ICMJE	October 2011
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 25, 2011)	Clinical Resolution [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ] The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15. Recurrence of Clinical Signs and Symptoms [ Time Frame: 6 Month ] [ Designated as safety issue: Yes ] The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
Original Primary Outcome Measures ^ICMJE (submitted: August 2, 2011)	Clinical Resolution [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ] The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution (score of 0) of signs and symptoms at Day 15. Recurrence of Clinical Signs and Symptoms [ Time Frame: 6 Month ] [ Designated as safety issue: Yes ] The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by Visit 10 (6-Month Follow-up). Recurrence is defined as a score of ≥4 from Day 15 in the study eye and must include a score of 1 for eyelid redness and a score of 1 for eyelid irritation.
Change History	Complete list of historical versions of study NCT01408082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
Official Title ^ICMJE	A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis
Brief Summary	The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Blepharitis
Intervention ^ICMJE	Drug: ISV-502 Azithromycin and Dexamethasone twice daily for 2 weeks Drug: Azasite Azasite twice daily for 2 weeks Drug: Dexamethasone Dexamethasone twice daily for 2 weeks Other: Vehicle Vehicle twice daily for 2 weeks
Study Arm (s)	Experimental: ISV-502 Intervention: Drug: ISV-502 Active Comparator: AzaSite Intervention: Drug: Azasite Active Comparator: Dexamethasone Intervention: Drug: Dexamethasone Placebo Comparator: Vehicle Intervention: Other: Vehicle
Publications *	Not Provided
* 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	Active, not recruiting
Estimated Enrollment ^ICMJE	900
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race. Signature of the subject or legally authorized representative on the Informed Consent Form. Are willing and able to follow all instructions and attend all study visits. Are willing to avoid disallowed medication for the duration of the study. If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months. Additional inclusion criteria also apply. Exclusion Criteria: Have known sensitivity or poor tolerance to any component of the Investigational Drug. Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye. Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters. Have used any non-diagnostic topical ophthalmic solutions in the study eye. Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test. Currently suffer from alcohol and/or drug abuse. Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device. Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation. Additional exclusion criteria also apply.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01408082
Other Study ID Numbers ^ICMJE	C-10-502-004
Has Data Monitoring Committee	Not Provided
Responsible Party	InSite Vision
Study Sponsor ^ICMJE	InSite Vision
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	InSite Vision
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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