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