HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and effective in the treatment of signs and symptoms of Dry Eye Disease.

Official Title
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HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: SYL1001 ophthalmic solution
* Drug: Vehicle opthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genders ≥ 18 years old Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks Common symptoms of persistent, daily, moderate to severe dry eye lasting more than six months. Use of artificial tears VAS scale for eye discomfort/pain between 30 - 80 CFS ≥ 2 and ≤ 4 on the Oxford scale TBUT < 10 seconds Hyperemia score ≥ 1 (McMonnies scale) Schirmer's test without anesthesia ≥ 2 and < 10 mm/5min in the eye Corrected visual acuity ≥ 0.7 logMAR Exclusion Criteria: Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study. Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes. Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement. Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period. Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development. Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development. Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment. Previous history of drug hypersensitivity. Use of contact lenses Case history of drug or alcohol abuse or dependence. Relevant abnormal laboratory results as judged by the investigator Previous refractive surgery Participation in a clinical trial within 2 months before the enrolment visit Relevant ocular pathology judged by the investigator.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 11.25 mg/mL SYL1001 ophthalmic solution<br>1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d | Drug: SYL1001 ophthalmic solution<br>* 1 drop in the affected eye<br>|
| Experimental: Vehicle ophthalmic solution<br>1 drop of vehicle ophthalmic solution in the affected eye(s) q.d | Drug: Vehicle opthalmic solution<br>* 1 drop in the affected eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle |  | 28 days | 
| Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle |  | 28 days | 
| Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SYL1001, siRNA