The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
328
Cyclosporine A solution in vehicle
Vehicle
CYS-003 Investigational Site
Newport Beach, California, United States
CYS-003 Investigational Site
Torrance, California, United States
CYS-003 Investigational Site
Indianapolis, Indiana, United States
CYS-003 Investigational Site
Change From Baseline in Total Corneal Fluorescein Staining at Day 29
CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Time frame: baseline and 1 month [day 29]
Change From Baseline in Ocular Surface Disease Index at Day 29
The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.
Time frame: baseline and 1 month [day 29]
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Louisville, Kentucky, United States
CYS-003 Investigational Site
Andover, Massachusetts, United States
CYS-003 Investigational Site
Raynham, Massachusetts, United States
CYS-003 Investigational Site
Memphis, Tennessee, United States
CYS-003 Investigational Site
Nashville, Tennessee, United States
CYS-003 Investigational Site
Norfolk, Virginia, United States