A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine

A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%

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.

Inclusion Criteria:

• Be at least 18 years of age;
• Provide written informed consent;
• Have a subject reported history of dry eye disease (DED) in both eyes
• Be able and willing to follow instructions, including participation in all trial assessments and visits.

Exclusion Criteria:

• Be a woman who is pregnant, nursing, or planning a pregnancy;
• Unwillingness to to use acceptable means of birth control
• Clinically significant slit-lamp findings or abnormal lid anatomy at screening
• Ongoing ocular or systemic infection at screening or baseline
• Presence of uncontrolled systemic diseases
• Presence of known allergy and/or sensitivity to the study drug or its components
• Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period
• Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly.
• Randomized in a previous CyclASol trial