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

February 12, 2019 updated by: Sylentis, S.A.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallin, Estonia, 10138
        • East Tallin Central Hospital
      • Tallinn, Estonia, 13419
        • Eye Clinic Dr. Krista Turman
      • Tartu, Estonia, 50406
        • Tartu University Hospital
  • Germany
      • Ahaus, Germany, 48683
        • Augenzentrum Nord-West
      • Dusseldorf, Germany, 40225
        • Universitäts-Augenklinik Düsseldorf
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Homburg, Germany
        • Universitätsklinikum des Saarlandes
      • Kiel, Germany
        • Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein
      • Köln, Germany
        • Uniklinik Köln Zentrum für Augenheilkunde
      • Leipzig, Germany
        • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
      • Munchen, Germany, 80336
        • Augenklinik der Ludwig-Maximilian Universität München
  • Italy
      • Firenze, Italy
        • AOU Careggi
      • Milan, Italy
        • Ospedale San Giuseppe
      • Padova, Italy
        • Farmacia Azienda Ospedaliera di Padova
      • Pisa, Italy
        • A.O.U. Pisana
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal
        • Centro Hospitalar E Universitário De Coimbra
      • Lisboa, Portugal, 1500-461
        • Hospital Lusíadas Lisboa
  • Slovakia
      • Martin, Slovakia, 03601
        • Bellet s.r.o
      • Trenčín, Slovakia, 911 01
        • Oftalmologická ambulancia
      • Trenčín, Slovakia, 911 71
        • Fakultná nemocnica Trenčín,
      • Štúrovo, Slovakia, 943 01
        • Optomedic s.r.o
      • Žilina, Slovakia, 012 07
        • Fakultna nemocnica s poliklinikou Zilina
      • Žilina, Slovakia, 01 001
        • OPHTHAMED, s.r.o.,
      • Žilina, Slovakia, 010 08
        • VIKOM s.r.o
  • Spain
      • Barcelona, Spain, 08017
        • Institut Catala de la Retina
      • Barcelona, Spain
        • Centro de Oftalmologia Barraquer
      • Barcelona, Spain, 08028
        • Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat
      • Barcelona, Spain, 08035
        • Instituto de Microcirugía Ocular (IMO)
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28043
        • Hospital Universitario Ramon y Cajal
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46017
        • FISABIO Oftalmología Médica (FOM)
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid
      • Zaragoza, Spain, 50004
        • Hospital Provincial Nuestra Señora de Gracia
    • Asturias
      • Oviedo, Asturias, Spain, 33012
        • Instituto Oftalmologico Fernandez Vega
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Hospital Universitario Príncipe de Asturias
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 11.25 mg/mL SYL1001 ophthalmic solution
1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d
Drug: SYL1001 ophthalmic solution
1 drop in the affected eye
EXPERIMENTAL: Vehicle ophthalmic solution
1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
Drug: Vehicle opthalmic solution
1 drop in the affected eye

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Time Frame: 28 days
28 days
Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle
Time Frame: 28 days
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sylentis, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYL1001_IV
  • 2016-003903-79 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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