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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108664
• Other study ID #: SYL1001_IV
• Secondary ID: 2016-003903-79
• Status: Completed
• Phase: Phase 3
• Start date: May 18, 2017
• Est. completion date: November 16, 2018

Study information

• Verified date: September 2018
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 16, 2018
• Est. primary completion date: October 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• SYL1001 ophthalmic solution
1 drop in the affected eye
• Vehicle opthalmic solution
1 drop in the affected eye

Locations

Country	Name	City	State
Estonia	East Tallin Central Hospital	Tallin
Estonia	Eye Clinic Dr. Krista Turman	Tallinn
Estonia	Tartu University Hospital	Tartu
Germany	Augenzentrum Nord-West	Ahaus
Germany	Universitäts-Augenklinik Düsseldorf	Dusseldorf
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Uniklinik Köln Zentrum für Augenheilkunde	Köln
Germany	Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde	Leipzig
Germany	Augenklinik der Ludwig-Maximilian Universität München	Munchen
Italy	AOU Careggi	Firenze
Italy	Ospedale San Giuseppe	Milan
Italy	Farmacia Azienda Ospedaliera di Padova	Padova
Italy	A.O.U. Pisana	Pisa
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar e Universitário de Coimbra	Coimbra
Portugal	Hospital Lusiadas Lisboa	Lisboa
Slovakia	Optomedic s.r.o	Štúrovo
Slovakia	Fakultná nemocnica s poliklinikou Žilina	Žilina
Slovakia	OPHTHAMED, s.r.o.,	Žilina
Slovakia	VIKOM s.r.o	Žilina
Slovakia	Bellet s.r.o	Martin
Slovakia	Fakultná nemocnica Trencín,	Trencín
Slovakia	Oftalmologická ambulancia	Trencín
Spain	Hospital Universitario Príncipe de Asturias	Alcala de Henares	Madrid
Spain	Centro de Oftalmología Barraquer	Barcelona
Spain	Institut Català de la Retina	Barcelona
Spain	Instituto de Microcirugía Ocular (IMO)	Barcelona
Spain	Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario la Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Instituto Oftalmológico Fernández Vega	Oviedo	Asturias
Spain	Clínica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	FISABIO Oftalmología Médica (FOM)	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Provincial Nuestra Señora de Gracia	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Countries where clinical trial is conducted

Estonia,  Germany,  Italy,  Portugal,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle		28 days
Primary	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
Primary	Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle		28 days
Secondary	Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability		28 days