CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (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.

Inclusion Criteria:

- Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and
Accountability Act)

- Patient-reported history of DED in both eyes

- Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms

- Ability and willingness to follow instructions, including participation in all study
assessments and visits

Exclusion Criteria:

- Women who are pregnant, nursing or planning a pregnancy

- Unwillingness to submit a urine pregnancy test at screening and the last visit (or
early termination visit) if of childbearing potential, or unwillingness to use
acceptable means of birth control

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

- Ocular/periocular malignancy

- History of herpetic keratitis

- Active ocular allergies or ocular allergies that may become active during the study
period

- Ongoing ocular or systemic infection at screening or baseline

- Wear of contact lenses within 3 months prior to screening or anticipated use of
contact lenses during the study

- History of no response to previous topical Cyclosporine A and/or use of topical
Cyclosporine A or Liftigrast within 2 months prior to screening

- Intraocular surgery or ocular laser surgery within the previous 6 months, or have any
planned ocular and/or lid surgeries over the study period

- Presence of uncontrolled systemic diseases

- Presence of known allergy and/or sensitivity to the study drug or its components