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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SYL1001 ophthalmic solution
Vehicle opthalmic solution
Sponsored by
Sylentis, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring SYL1001, siRNA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eye Clinic Dr. Krista Turman
  • East Tallin Central Hospital
  • Tartu University Hospital
  • Augenzentrum Nord-West
  • Universitäts-Augenklinik Düsseldorf
  • Universitätsklinikum Freiburg
  • Universitätsklinikum des Saarlandes
  • Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein
  • Uniklinik Köln Zentrum für Augenheilkunde
  • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
  • Augenklinik der Ludwig-Maximilian Universität München
  • AOU Careggi
  • Ospedale San Giuseppe
  • Farmacia Azienda Ospedaliera di Padova
  • A.O.U. Pisana
  • Hospital de Braga
  • Centro Hospitalar e Universitário de Coimbra
  • Hospital Lusiadas Lisboa
  • Bellet s.r.o
  • Oftalmologická ambulancia
  • Fakultná nemocnica Trenčín,
  • Optomedic s.r.o
  • OPHTHAMED, s.r.o.,
  • VIKOM s.r.o
  • Fakultná nemocnica s poliklinikou Žilina
  • Instituto Oftalmológico Fernández Vega
  • Hospital Universitario Príncipe de Asturias
  • Clínica Universidad de Navarra
  • Institut Català de la Retina
  • Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat
  • Instituto de Microcirugía Ocular (IMO)
  • Centro de Oftalmología Barraquer
  • Hospital Clínico San Carlos
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario la Paz
  • Hospital Universitario Virgen Macarena
  • FISABIO Oftalmología Médica (FOM)
  • Hospital Clínico Universitario de Valladolid
  • Hospital Provincial Nuestra Señora de Gracia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

11.25 mg/mL SYL1001 ophthalmic solution

Vehicle ophthalmic solution

Arm Description

1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d

1 drop of vehicle ophthalmic solution in the affected eye(s) q.d

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability

Full Information

First Posted
March 30, 2017
Last Updated
February 12, 2019
Sponsor
Sylentis, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03108664
Brief Title
HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)
Official Title
HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
October 16, 2018 (Actual)
Study Completion Date
November 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
SYL1001, siRNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
11.25 mg/mL SYL1001 ophthalmic solution
Arm Type
Experimental
Arm Description
1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d
Arm Title
Vehicle ophthalmic solution
Arm Type
Experimental
Arm Description
1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
Intervention Type
Drug
Intervention Name(s)
SYL1001 ophthalmic solution
Intervention Description
1 drop in the affected eye
Intervention Type
Drug
Intervention Name(s)
Vehicle opthalmic solution
Intervention Description
1 drop in the affected eye
Primary Outcome Measure Information:
Title
Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle
Time Frame
28 days
Title
Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle
Time Frame
28 days
Title
Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Eye Clinic Dr. Krista Turman
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
East Tallin Central Hospital
City
Tallin
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Augenzentrum Nord-West
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
Facility Name
Universitäts-Augenklinik Düsseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
Country
Germany
Facility Name
Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Uniklinik Köln Zentrum für Augenheilkunde
City
Köln
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
City
Leipzig
Country
Germany
Facility Name
Augenklinik der Ludwig-Maximilian Universität München
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
AOU Careggi
City
Firenze
Country
Italy
Facility Name
Ospedale San Giuseppe
City
Milan
Country
Italy
Facility Name
Farmacia Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
A.O.U. Pisana
City
Pisa
Country
Italy
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar e Universitário de Coimbra
City
Coimbra
Country
Portugal
Facility Name
Hospital Lusiadas Lisboa
City
Lisboa
ZIP/Postal Code
1500-461
Country
Portugal
Facility Name
Bellet s.r.o
City
Martin
ZIP/Postal Code
03601
Country
Slovakia
Facility Name
Oftalmologická ambulancia
City
Trenčín
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Fakultná nemocnica Trenčín,
City
Trenčín
ZIP/Postal Code
911 71
Country
Slovakia
Facility Name
Optomedic s.r.o
City
Štúrovo
ZIP/Postal Code
943 01
Country
Slovakia
Facility Name
OPHTHAMED, s.r.o.,
City
Žilina
ZIP/Postal Code
01 001
Country
Slovakia
Facility Name
VIKOM s.r.o
City
Žilina
ZIP/Postal Code
010 08
Country
Slovakia
Facility Name
Fakultná nemocnica s poliklinikou Žilina
City
Žilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Instituto Oftalmológico Fernández Vega
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
Facility Name
Hospital Universitario Príncipe de Asturias
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Institut Català de la Retina
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Instituto de Microcirugía Ocular (IMO)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Centro de Oftalmología Barraquer
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28043
Country
Spain
Facility Name
Hospital Universitario la Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
FISABIO Oftalmología Médica (FOM)
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
Country
Spain
Facility Name
Hospital Provincial Nuestra Señora de Gracia
City
Zaragoza
ZIP/Postal Code
50004
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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