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

NCT03108664 | Completed Phase 3

• 2 other identifiers: SYL1001_IV2016-003903-79
• Study Type: interventional
• Target: 330
• Locations: 5 countries
• Sites: 37

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

Keywords

SYL1001; siRNA

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability

  28 days

Study Arms (2)

11.25 mg/mL SYL1001 ophthalmic solution

EXPERIMENTAL

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

Drug: SYL1001 ophthalmic solution

Vehicle ophthalmic solution

EXPERIMENTAL

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

Drug: Vehicle opthalmic solution

Interventions

SYL1001 ophthalmic solution DRUG

1 drop in the affected eye

11.25 mg/mL SYL1001 ophthalmic solution

Vehicle opthalmic solution DRUG

1 drop in the affected eye

Vehicle ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sylentis, S.A.: lead

Study Sites (40)

East Tallin Central Hospital

Tallinn, 10138, Estonia

Location

Eye Clinic Dr. Krista Turman

Tallinn, 13419, Estonia

Location

Tartu University Hospital

Tartu, 50406, Estonia

Location

Augenzentrum Nord-West

Ahaus, 48683, Germany

Location

Uniklinik Köln Zentrum für Augenheilkunde

Cologne, Germany

Location

Universitäts-Augenklinik Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Germany

Location

Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde

Leipzig, Germany

Location

Augenklinik der Ludwig-Maximilian Universität München

München, 80336, Germany

Location

AOU Careggi

Florence, Italy

Location

Ospedale San Giuseppe

Milan, Italy

Location

Farmacia Azienda Ospedaliera di Padova

Padua, Italy

Location

A.O.U. Pisana

Pisa, Italy

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal

Location

Hospital Lusiadas Lisboa

Lisbon, 1500-461, Portugal

Location

Bellet s.r.o

Martin, 03601, Slovakia

Location

Optomedic s.r.o

Štúrovo, 943 01, Slovakia

Location

Oftalmologická ambulancia

Trenčín, 911 01, Slovakia

Location

Fakultná nemocnica Trenčín,

Trenčín, 911 71, Slovakia

Location

OPHTHAMED, s.r.o.,

Žilina, 01 001, Slovakia

Location

VIKOM s.r.o

Žilina, 010 08, Slovakia

Location

Fakultná nemocnica s poliklinikou Žilina

Žilina, 012 07, Slovakia

Location

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Instituto Oftalmológico Fernández Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Institut Català de la Retina

Barcelona, 08017, Spain

Location

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

Barcelona, 08028, Spain

Location

Instituto de Microcirugía Ocular (IMO)

Barcelona, 08035, Spain

Location

Centro de Oftalmología Barraquer

Barcelona, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28043, Spain

Location

Hospital Universitario la Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

FISABIO Oftalmología Médica (FOM)

Valencia, 46017, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Location

Hospital Provincial Nuestra Señora de Gracia

Zaragoza, 50004, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: May 18, 2017
• Primary Completion: October 16, 2018
• Study Completion: November 16, 2018
• Last Updated: February 15, 2019

Record last verified: 2018-09

Locations

ES (15); DE (8); IT (4); PT (3); SL (7)