Clinical trial NCT03108664: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: SYL1001
siRNA
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle
timeFrame: 28 days
measure: Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle
timeFrame: 28 days
measure: Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle
timeFrame: 28 days
Secondary outcomes:
measure: Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
timeFrame: 28 days
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Eye Clinic Dr. Krista Turman
city: Tallin
country: Estonia
facility: East Tallin Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Ahaus
country: Germany
facility: Augenzentrum Nord-West
city: Dusseldorf
country: Germany
facility: Universitäts-Augenklinik Düsseldorf
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Kiel
country: Germany
facility: Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein
city: Köln
country: Germany
facility: Uniklinik Köln Zentrum für Augenheilkunde
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
city: Munchen
country: Germany
facility: Augenklinik der Ludwig-Maximilian Universität München
city: Firenze
country: Italy
facility: AOU Careggi
city: Milan
country: Italy
facility: Ospedale San Giuseppe
city: Padova
country: Italy
facility: Farmacia Azienda Ospedaliera di Padova
city: Pisa
country: Italy
facility: A.O.U. Pisana
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
city: Lisboa
country: Portugal
facility: Hospital Lusiadas Lisboa
city: Martin
country: Slovakia
facility: Bellet s.r.o
city: Trenčín
country: Slovakia
facility: Oftalmologická ambulancia
city: Trenčín
country: Slovakia
facility: Fakultná nemocnica Trenčín,
city: Štúrovo
country: Slovakia
facility: Optomedic s.r.o
city: Žilina
country: Slovakia
facility: OPHTHAMED, s.r.o.,
city: Žilina
country: Slovakia
facility: VIKOM s.r.o
city: Žilina
country: Slovakia
facility: Fakultná nemocnica s poliklinikou Žilina
city: Oviedo
country: Spain
facility: Instituto Oftalmológico Fernández Vega
state: Asturias
city: Alcala de Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Institut Català de la Retina
city: Barcelona
country: Spain
facility: Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat
city: Barcelona
country: Spain
facility: Instituto de Microcirugía Ocular (IMO)
city: Barcelona
country: Spain
facility: Centro de Oftalmología Barraquer
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: FISABIO Oftalmología Médica (FOM)
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Provincial Nuestra Señora de Gracia
Study officials:
References: