Trial record 16 of 21 for: Open Studies | "Eyelid Diseases"
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Non-Bacterial Blepharitis Subjects
This study is not yet open for participant recruitment.
Verified September 2013 by InSite Vision
Information provided by (Responsible Party):
First received: February 28, 2012
Last updated: September 17, 2013
Last verified: September 2013
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite®) compared to Vehicle in the treatment of subjects with Non-Bacterial Blepharitis.
|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 Efficacy and Safety of ISV-305 (Dexamethasone in DuraSite®) Compared to Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by InSite Vision:
Primary Outcome Measures:
- Clinical Resolution [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]The primary efficacy endpoint for the comparison of ISV-305 and Vehicle is complete clinical resolution of signs and symptoms at Day 15.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Dexamethasone in DuraSite® twice daily for 2 weeks
|Placebo Comparator: Vehicle||
Placebo twice daily for 2 weeks
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543490
|Contact: Judith Hutchesonfirstname.lastname@example.org|
Sponsors and Collaborators