CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

Inclusion Criteria

• Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
• Patient-reported history of dry eye in both eyes
• Current use of over-the-counter and/or prescription eye drops 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 blood pregnancy test at screening and at 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
• DED secondary to scarring or ocular or periocular malignancy
• History of herpetic keratitis
• Active ocular allergies or ocular allergies that are expected to be 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 within 6 months prior to screening
• Intra-ocular 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 an uncontrolled systemic disease
• Presence of a known allergy and/or sensitivity to the study drug or its components