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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: SYL1001 ophthalmic solution; Drug: Vehicle opthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 3

Contacts and Locations

Study Locations

• Estonia
  • Tallin, Estonia, 10138
    • East Tallin Central Hospital
  • Tallinn, Estonia, 13419
    • Eye Clinic Dr. Krista Turman
  • Tartu, Estonia, 50406
    • Tartu University Hospital
• Germany
  • Ahaus, Germany, 48683
    • Augenzentrum Nord-West
  • Dusseldorf, Germany, 40225
    • Universitäts-Augenklinik Düsseldorf
  • Freiburg, Germany
    • Universitätsklinikum Freiburg
  • Homburg, Germany
    • Universitätsklinikum des Saarlandes
  • Kiel, Germany
    • Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein
  • Köln, Germany
    • Uniklinik Köln Zentrum für Augenheilkunde
  • Leipzig, Germany
    • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
  • Munchen, Germany, 80336
    • Augenklinik der Ludwig-Maximilian Universität München
• Italy
  • Firenze, Italy
    • AOU Careggi
  • Milan, Italy
    • Ospedale San Giuseppe
  • Padova, Italy
    • Farmacia Azienda Ospedaliera di Padova
  • Pisa, Italy
    • A.O.U. Pisana
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal
    • Centro Hospitalar e Universitario de Coimbra
  • Lisboa, Portugal, 1500-461
    • Hospital Lusíadas Lisboa
• Slovakia
  • Martin, Slovakia, 03601
    • Bellet s.r.o
  • Trenčín, Slovakia, 911 01
    • Oftalmologická ambulancia
  • Trenčín, Slovakia, 911 71
    • Fakultná nemocnica Trenčín,
  • Štúrovo, Slovakia, 943 01
    • Optomedic s.r.o
  • Žilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou Zilina
  • Žilina, Slovakia, 01 001
    • OPHTHAMED, s.r.o.,
  • Žilina, Slovakia, 010 08
    • VIKOM s.r.o
• Spain
  • Barcelona, Spain, 08017
    • Institut Catala de la Retina
  • Barcelona, Spain
    • Centro de Oftalmologia Barraquer
  • Barcelona, Spain, 08028
    • Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat
  • Barcelona, Spain, 08035
    • Instituto de Microcirugía Ocular (IMO)
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28043
    • Hospital Universitario Ramon y Cajal
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46017
    • FISABIO Oftalmología Médica (FOM)
  • Valladolid, Spain
    • Hospital Clinico Universitario de Valladolid
  • Zaragoza, Spain, 50004
    • Hospital Provincial Nuestra Señora de Gracia
  • Asturias
    • Oviedo, Asturias, Spain, 33012
      • Instituto Oftalmologico Fernandez Vega
  • Madrid
    • Alcala de Henares, Madrid, Spain, 28805
      • Hospital Universitario Príncipe de Asturias
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 11.25 mg/mL SYL1001 ophthalmic solution; 1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d	Drug: SYL1001 ophthalmic solution; 1 drop in the affected eye
EXPERIMENTAL: Vehicle ophthalmic solution; 1 drop of vehicle ophthalmic solution in the affected eye(s) q.d	Drug: Vehicle opthalmic solution; 1 drop in the affected eye

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sylentis, S.A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2017
• Primary Completion (ACTUAL): October 16, 2018
• Study Completion (ACTUAL): November 16, 2018

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (ACTUAL): April 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: siRNA; SYL1001
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: SYL1001_IV; 2016-003903-79 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No