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

Phase 2

Completed

Interventions: Drug: Vehicle topical ocular, eye drops
Drug: CyclASol topical ocular, eye drops

Brief Summary: The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.

Detailed Description: This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vehicle Ophthalmic Solution	Vehicle topical ocular, eye drops	Vehicle only
CyclASol Ophthalmic Solution	CyclASol topical ocular, eye drops	Cylclosporine A solution in vehicle

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Surface Disease Index at Day 29	baseline and 1 month [day 29]	The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.
Change From Baseline in Total Corneal Fluorescein Staining at Day 29	baseline and 1 month [day 29]	CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.

Secondary Outcome Measures