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

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: SYL1001 ophthalmic solution; Drug: Vehicle opthalmic solution

• Registration Number: NCT03108664
• Lead Sponsor: Sylentis, S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-05-18
• Status Verified: 2018-09
• Primary Completion: 2018-10-16
• Study Completion: 2018-11-16
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
11.25 mg/mL SYL1001 ophthalmic solution	SYL1001 ophthalmic solution	1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d
Vehicle ophthalmic solution	Vehicle opthalmic solution	1 drop of vehicle ophthalmic solution in the affected eye(s) q.d

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability	28 days

Trial Locations

Locations (40)

Eye Clinic Dr. Krista Turman; 🇪🇪 Tallinn, Estonia

East Tallin Central Hospital; 🇪🇪 Tallin, Estonia

Tartu University Hospital; 🇪🇪 Tartu, Estonia

Augenzentrum Nord-West; 🇩🇪 Ahaus, Germany

Universitäts-Augenklinik Düsseldorf; 🇩🇪 Dusseldorf, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Uniklinik Köln Zentrum für Augenheilkunde; 🇩🇪 Köln, Germany

Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde; 🇩🇪 Leipzig, Germany

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