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

NCT ID: NCT03108664

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-18
• Study Completion Date: 2018-11-16

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.

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

11.25 mg/mL SYL1001 ophthalmic solution

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

Group Type: EXPERIMENTAL

SYL1001 ophthalmic solution

Intervention Type: DRUG

1 drop in the affected eye

Vehicle ophthalmic solution

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

Group Type: EXPERIMENTAL

Vehicle opthalmic solution

Intervention Type: DRUG

1 drop in the affected eye

Interventions

SYL1001 ophthalmic solution

1 drop in the affected eye

Intervention Type: DRUG

Vehicle opthalmic solution

1 drop in the affected eye

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sylentis, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

East Tallin Central Hospital

Tallinn, , Estonia

Eye Clinic Dr. Krista Turman

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Augenzentrum Nord-West

Ahaus, , Germany

Uniklinik Köln Zentrum für Augenheilkunde

Cologne, , Germany

Universitäts-Augenklinik Düsseldorf

Düsseldorf, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitätsklinikum des Saarlandes

Homburg, , Germany

Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde

Leipzig, , Germany

Augenklinik der Ludwig-Maximilian Universität München

München, , Germany

AOU Careggi

Florence, , Italy

Ospedale San Giuseppe

Milan, , Italy

Farmacia Azienda Ospedaliera di Padova

Padua, , Italy

A.O.U. Pisana

Pisa, , Italy

Hospital de Braga

Braga, , Portugal

Centro Hospitalar e Universitário de Coimbra

Coimbra, , Portugal

Hospital Lusiadas Lisboa

Lisbon, , Portugal

Bellet s.r.o

Martin, , Slovakia

Optomedic s.r.o

Štúrovo, , Slovakia

Oftalmologická ambulancia

Trenčín, , Slovakia

Fakultná nemocnica Trenčín,

Trenčín, , Slovakia

OPHTHAMED, s.r.o.,

Žilina, , Slovakia

VIKOM s.r.o

Žilina, , Slovakia

Fakultná nemocnica s poliklinikou Žilina

Žilina, , Slovakia

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Instituto Oftalmológico Fernández Vega

Oviedo, Principality of Asturias, Spain

Institut Català de la Retina

Barcelona, , Spain

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

Barcelona, , Spain

Instituto de Microcirugía Ocular (IMO)

Barcelona, , Spain

Centro de Oftalmología Barraquer

Barcelona, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario la Paz

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

FISABIO Oftalmología Médica (FOM)

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Provincial Nuestra Señora de Gracia

Zaragoza, , Spain

Countries

Estonia; Germany; Italy; Portugal; Slovakia; Spain

Other Identifiers

2016-003903-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SYL1001_IV

Identifier Type: -

Identifier Source: org_study_id