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

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 trialassessments and visits.

Exclusion Criteria:

• Be a woman who is pregnant, nursing, or planning a pregnancy;

• Unwillingness to submit a urine pregnancy test at screening and the last visit (orearly termination visit) if of childbearing potential, or unwillingness to useacceptable means of birth control

• Clinically significant slit-lamp findings or abnormal lid anatomy at screening

• Ocular/periocular malignancy

• History of herpetic keratitis

• Have any primary or secondary corneal endothelial disorder such as Fuchs dystrophyor other endothelial dystrophy, significant guttata

• 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 daysbefore Visit 1, or have any planned ocular surgeries during the trial period;

• Have a known allergy or sensitivity to the IMP or its components

• Have a condition or be in a situation which the Investigator feels may put thesubject at significant risk, may confound the trial results, or may interfere withthe subject's participation in the trial significantly.

• Randomized in a previous CyclASol trial