The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)
The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
Colorless and clear opthalmic solution containing 0.1% Cyclosporine
Colorless and clear sodium chloride solution (0.6%)
CYS-007 Investigational Site
Newport Beach, California, United States
CYS-007 Investigational Site
Torrance, California, United States
CYS-007 Investigational Site
Garner, North Carolina, United States
CYS-007 Investigational Site
Shelby, North Carolina, United States
Change From Baseline in Corneal Endothelial Cell Density (ECD)
Change from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye
Time frame: 12 months
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CYS-007 Investigational Site
Cranberry Township, Pennsylvania, United States
CYS-007 Investigational Site
Memphis, Tennessee, United States