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

Study Overview
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Brief Summary
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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
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This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.

Official Title
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A Phase 2b/3, Multicenter, Randomized, Double-masked, Vehicle-controlled Clinical Study to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (ESSENCE Trial)

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: CyclASol topical ocular, eye drops
* Drug: Vehicle topical ocular, eye drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyclASol Ophthalmic Solution<br>Cylclosporine A solution in vehicle | Drug: CyclASol topical ocular, eye drops<br>* Cyclosporine A solution in vehicle<br>* Other names: Ciclosporine (CsA);|
| Placebo Comparator: Vehicle Ophthalmic Solution<br>Vehicle only | Drug: Vehicle topical ocular, eye drops<br>* Vehicle<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Corneal Fluorescein Staining at 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. | baseline and 1 month [day 29] | 
| Change From Baseline in Ocular Surface Disease Index at 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. | baseline and 1 month [day 29] |