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Dry Eye DiseasePhase 3NCT03108664

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

A Phase 3 study testing SYL1001 ophthalmic solution in people with Dry Eye Disease, run by Sylentis, S.A. at 40 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
SYL1001 ophthalmic solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
40 sitesin 6 countries
Study dates
18 May 2017to 16 Nov 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

40 sites in 6 countries.

40 sites in 6 countries

Spain15 sites

  • Hospital Universitario Príncipe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Institut Català de la Retina

    Barcelona, 08017

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

    Barcelona, 08028

  • Instituto de Microcirugía Ocular (IMO)

    Barcelona, 08035

  • Centro de Oftalmología Barraquer

    Barcelona

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario Ramón y Cajal

    Madrid, 28043

  • Hospital Universitario la Paz

    Madrid, 28046

  • Instituto Oftalmológico Fernández Vega

    Oviedo, Principality of Asturias, 33012

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • FISABIO Oftalmología Médica (FOM)

    Valencia, 46017

  • Hospital Clínico Universitario de Valladolid

    Valladolid

  • Hospital Provincial Nuestra Señora de Gracia

    Zaragoza, 50004

Other trials in Spain

Germany8 sites

  • Augenzentrum Nord-West

    Ahaus, 48683

  • Uniklinik Köln Zentrum für Augenheilkunde

    Cologne

  • Universitäts-Augenklinik Düsseldorf

    Düsseldorf, 40225

  • 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

  • Augenklinik der Ludwig-Maximilian Universität München

    München, 80336

Other trials in Germany

Slovakia7 sites

  • Bellet s.r.o

    Martin, 03601

  • Optomedic s.r.o

    Štúrovo, 943 01

  • Oftalmologická ambulancia

    Trenčín, 911 01

  • Fakultná nemocnica Trenčín,

    Trenčín, 911 71

  • OPHTHAMED, s.r.o.,

    Žilina, 01 001

  • VIKOM s.r.o

    Žilina, 010 08

  • Fakultná nemocnica s poliklinikou Žilina

    Žilina, 012 07

Other trials in Slovakia

Italy4 sites

  • AOU Careggi

    Florence

  • Ospedale San Giuseppe

    Milan

  • Farmacia Azienda Ospedaliera di Padova

    Padova

  • A.O.U. Pisana

    Pisa

Other trials in Italy

Estonia3 sites

  • East Tallin Central Hospital

    Tallinn, 10138

  • Eye Clinic Dr. Krista Turman

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 50406

Other trials in Estonia

Portugal3 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra

    Coimbra

  • Hospital Lusiadas Lisboa

    Lisbon, 1500-461

Other trials in Portugal

About this study

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

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
Being tested
SYL1001 ophthalmic solution, Vehicle opthalmic solution
Keywords
SYL1001, siRNA
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYL1001 ophthalmic solutionDrug

    1 drop in the affected eye

  • Vehicle opthalmic solutionDrug

    1 drop in the affected eye

Study groups in NCT03108664
Study groupRoleWhat they receive
11.25 mg/mL SYL1001 ophthalmic solutionExperimental1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d
Receives: Drug: SYL1001 ophthalmic solution
Vehicle ophthalmic solutionExperimental1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
Receives: Drug: Vehicle opthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle

    Measured: 28 days

  2. Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle

    Measured: 28 days

  3. Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle

    Measured: 28 days

Secondary outcomes (1)

  1. Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study start18 May 2017
  3. Primary completion16 Oct 2018
  4. Study completion16 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03108664
Sponsor's protocol ID
SYL1001_IV
Other IDs
2016-003903-79, 2016
Status last verified
Sep 2018
First submitted
30 Mar 2017
Last updated
15 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYL1001 ophthalmic solution in people with Dry Eye Disease, run by Sylentis, S.A. at 40 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Spain, Germany, Slovakia, Italy, Estonia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03108664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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