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

PHASE3CompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

May 18, 2017

Primary Completion Date

October 16, 2018

Study Completion Date

November 16, 2018

Conditions
Dry Eye Disease
Interventions
DRUG

SYL1001 ophthalmic solution

1 drop in the affected eye

DRUG

Vehicle opthalmic solution

1 drop in the affected eye

Trial Locations (40)

10138

East Tallin Central Hospital, Tallinn

13419

Eye Clinic Dr. Krista Turman, Tallinn

28040

Hospital Clínico San Carlos, Madrid

Hospital Universitario Fundación Jiménez Díaz, Madrid

28043

Hospital Universitario Ramón y Cajal, Madrid

28046

Hospital Universitario la Paz, Madrid

28805

Hospital Universitario Príncipe de Asturias, Alcalá de Henares

31008

Clínica Universidad de Navarra, Pamplona

33012

Instituto Oftalmológico Fernández Vega, Oviedo

40225

Universitäts-Augenklinik Düsseldorf, Düsseldorf

41009

Hospital Universitario Virgen Macarena, Seville

46017

FISABIO Oftalmología Médica (FOM), Valencia

48683

Augenzentrum Nord-West, Ahaus

50004

Hospital Provincial Nuestra Señora de Gracia, Zaragoza

50406

Tartu University Hospital, Tartu

80336

Augenklinik der Ludwig-Maximilian Universität München, München

Unknown

Uniklinik Köln Zentrum für Augenheilkunde, Cologne

Universitätsklinikum Freiburg, Freiburg im Breisgau

Universitätsklinikum des Saarlandes, Homburg

Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein, Kiel

Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde, Leipzig

AOU Careggi, Florence

Ospedale San Giuseppe, Milan

Farmacia Azienda Ospedaliera di Padova, Padua

A.O.U. Pisana, Pisa

Centro Hospitalar e Universitário de Coimbra, Coimbra

Centro de Oftalmología Barraquer, Barcelona

Hospital Clínico Universitario de Valladolid, Valladolid

4710-243

Hospital de Braga, Braga

1500-461

Hospital Lusiadas Lisboa, Lisbon

03601

Bellet s.r.o, Martin

943 01

Optomedic s.r.o, Štúrovo

911 01

Oftalmologická ambulancia, Trenčín

911 71

Fakultná nemocnica Trenčín,, Trenčín

01 001

OPHTHAMED, s.r.o.,, Žilina

010 08

VIKOM s.r.o, Žilina

012 07

Fakultná nemocnica s poliklinikou Žilina, Žilina

08017

Institut Català de la Retina, Barcelona

08028

Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat, Barcelona

08035

Instituto de Microcirugía Ocular (IMO), Barcelona

All Listed Sponsors
lead

Sylentis, S.A.

INDUSTRY

NCT03108664 - HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED) | Biotech Hunter | Biotech Hunter