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    Summary
    EudraCT Number:2016-003903-79
    Sponsor's Protocol Code Number:SYL1001_IV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-31
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003903-79
    A.3Full title of the trial
    A double-masked study of
    SYL1001 in patients with moderate to severe dry eye disease (DED).
    Uno studio in doppio cieco su SYL1001 nei pazienti con sindrome dell'occhio secco
    (DED) da moderata a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-masked study of SYL1001 in patients with moderate to
    severe dry eye disease (DED).
    Uno studio in doppio cieco su SYL1001 nei
    pazienti con sindrome dell'occhio secco (DED) da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    HELIX
    HELIX
    A.4.1Sponsor's protocol code numberSYL1001_IV
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSYLENTIS S.A.U
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSylentis SAU
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSylentis SAU
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressC/Santiago Grisolia n.2 - (PTM)
    B.5.3.2Town/ cityTres Cantos, Madrid
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+34919063188
    B.5.5Fax number+34918049597
    B.5.6E-mailvruz@sylentis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSYL1001
    D.3.2Product code SYL1001
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe dry eye disease (DED)
    Sindrome dell'occhio secco (DED) da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Moderate to severe dry eye disease
    Sindrome dell'occhio secco da moderata a grave
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of efficacy of SYL1001 at 11.25
    mg/mL on signs and symptoms of DED
    Valutazione dell'efficacia della soluzione SYL1001 (11.25 mg/ml) sui segni e i sintomi della Sindrome
    dell'occhio secco
    E.2.2Secondary objectives of the trial
    Safety assessment : local and systemic
    tolerability, and Adverse Events
    Valutazione della sicurezza: tollerabilità sistemica e locale, ed eventi avversi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Patient is a male or a female aged ≥ 18 years at screening visit. 2) Have given their written consent to participate in the study,
    after having received all information relating to the design, aims and possible
    risks resulting therefrom. 3)Common symptoms of persistent, daily, moderate to severe dry eye
    lasting more than six months. 4)Use of artificial tears during the last 30 days prior to the selection phase
    5)VAS scale for eye discomfort/pain between 30 - 80 in one of the eyes and ≥ 20 in the fellow eye.
    6)CFS ≥ 2 and ≤ 4 on the Oxford scale (0-5) in at least 1 eye region in the eye with the highest VAS scoring for eye
    discomfort/pain. 7)TBUT < 10 seconds in the eye with the highest VAS scoring for eye discomfort/pain. TBUT ≥1 in both eyes.
    8)Hyperemia score ≥1 (McMonnies scale) in the eye with the highest VAS scoring for eye discomfort/pain. 9)Schirmer's test
    without anesthesia ≥ 2 and < 10 mm/5min in the eye with the highest VAS scoring for eye discomfort/pain. Value ≥ 2 in the fellow
    eye. 10)Corrected visual acuity ≥ 0.7 logMAR (20/100 Snellen or 50 ETDRS) in both eyes.11)If the subject is selected in a French
    site, he/she must be covered by a National Social Security System at screening visit.
    1)Il paziente è un uomo o una donna di età ≥ 18 anni al momento della visita di screening. 2)Presenza di consenso scritto a
    partecipare allo studio, dopo aver ricevuto tutte le informazioni relative al progetto, agli obiettivi e agli eventuali rischi che ne
    derivano. 3)Sintomi più comuni di secchezza oculare persistente quotidiana, da moderata a grave, con durata superiore a sei
    mesi.4) Uso di lacrime artificiali durante gli ultimi 30 giorni prima della fase di selezione. 5)Scala VAS per fastidio/dolore a un
    occhio tra 30 - 80 in uno degli occhi e almeno ≥ 20 nell'altro occhio. 6)CFS ≥ 2 e ≤ 4 sulla scala Oxford (0-5) in almeno 1 regione
    oculare nell'occhio con il più alto punteggio VAS per fastidio/dolore oculare. 7) TBUT < 10 secondi nell'occhio con il più alto
    punteggio VAS per fastidio/dolore oculare. TBUT ≥1 in entrambi gli occhi. 8) Punteggio iperemia ≥ 1 (scala
    McMonnies) nell'occhio con il più alto punteggio VAS per fastidio/dolore oculare. 9) Test di Schirmer senza anestesia ≥ 2 e <10
    mm/5min nell'occhio
    con il più alto punteggio VAS per fastidio/dolore oculare. Valore ≥2 nell'altro occhio.10) Acuità visiva corretta ≥ 0,7logMAR (20/100
    Snellen o 50 ETDRS) in entrambi gli occhi.11)Se il soggetto viene selezionato in un centro francese, deve essere
    coperto dal Sistema Nazionale di Previdenza Sociale al momento della visita di screening.
    E.4Principal exclusion criteria
    1)Pregnant or breastfeeding females or females with a positive pregnancy test at the screening visits. 2)Females of childbearing
    potential not willing to use
    a medically acceptable contraceptive method (definition in section 6.3) from enrolment until after the final visit. 3)Current,
    previous chronic or recurrent medical condition which, according to the investigator, might impact the interpretation of the study
    results or put the subject at risk.4)Current concomitant use of any medications with analgesic activity (such as regular pain killer
    users) by any route of administration at the time of entry into the study and during the study. 5)Change in concomitant systemic
    medication one month before the study and during the study that might impact the interpretation of the results according to the
    investigator. 6)Concomitant treatment with cyclosporine, tacrolimus, sirolimus (systemic or ophthalmic) for the previous 2 months
    before entering the study. 7)Any eye concomitant treatment at the time of entry into the study. Unpreserved artificial tears will be
    provided by the Sponsor to use throughout the study. A maximum of 4 daily drops is allowed. 8)History of hypersensitivity to
    SYL1001, to any component of the formulation or to ophthalmic diagnostic agents. 9)Use of contact lenses or punctual plugs
    during the treatment and the previous 7 days (prior to treatment initiation). 10)Clinically significant laboratory abnormalities
    according to investigator's opinion. 11)Previous refractive surgery, cornea transplant. Meibomian gland dysfunction or history of lid
    malposition (ectropion, entropion, ptosis) that may affect acurate assessment of the disease and/or mask the effects of the drug.
    12)Any other ocular surgery in the past 1 year. 13)Any other eye disease that is significant in the investigator's opinion.
    14)Currently participating or having participated in another clinical trial within the 2 months prior to inclusion. Patient that already
    participatedin SYL1001_IV trial.15) Non-compliance after the run-in period.
    1)Donne incinte o in allattamento, o donne con un
    test di gravidanza positivo al momento della visita
    di screening. 2)Donne in età fertile non disposte a utilizzare un metodo contraccettivo clinicamente accettabile (definizione nella
    sezione 6.3) dall'arruolamento fino a dopo l'ultima visita. 3)Condizione medica attuale, precedente cronica o ricorrente che,
    secondo lo sperimentatore, potrebbe
    avere un impatto sull'interpretazione dei risultati
    dello studio o mettere il soggetto a rischio.
    4. Uso concomitante di farmaci con attività analgesica (come normali antidolorifici) per qualsiasi via di somministrazione al
    momento dell'ingresso nello studio e durante lo studio. 5)Cambiamento nella terapia sistemica concomitante un mese prima dello
    studio e durante lo studio che potrebbe avere un impatto sull'interpretazione dei risultati secondo lo sperimentatore.
    6)Trattamento concomitante con ciclosporina, tacrolimus, sirolimus (sistemica o oftalmica) per i precedenti 2 mesi prima
    dell'ingresso nello studio. 7)Ogni trattamento oculare concomitante al momento dell'ingresso nello studio. Lo sponsor fornirà
    lacrime artificiali senza conservanti da utilizzare durante tutto lo studio. È consentito un massimo di 4 gocce al giorno. 8) Storia di
    ipersensibilità all'SYL1001, a qualsiasi componente della formulazione o ad agenti diagnostici oftalmici.
    9)Uso di lenti a contatto o Punctal Plugs durante il
    trattamento e nei 7 giorni precedenti (prima dell'inizio del trattamento). 10)Anomalie di laboratorio clinicamente significative
    secondo l'opinione dello sperimentatore. 11)Chirurgia refrattiva precedente, trapianto di cornea. Disfunzione della ghiandola di
    Meibomio o storia di malposizionamento della palpebra (ectropion,entropion, ptosi) in grado di influenzare la valutazione accurata
    della malattia e/o mascherare gli effetti del farmaco. 12)Qualsiasi altro intervento oculare nel precedente anno.13)Qualsiasi altra
    malattia degli occhi che è rilevante secondo l'opinione dello sperimentatore.14)Persone che partecipano attualmente o hanno
    partecipato a un altro studio clinico durante i 2 mesi precedenti all'inclusione. Il paziente ha già partecipato alla sperimentazione
    SYL1001_IV. 15) Non conformità dopo il periodo di preparazione.
    E.5 End points
    E.5.1Primary end point(s)
    -Change from Baseline in Visual Analogue
    Scale (VAS) scores for eye discomfort/pain after 28 days of treatment.
    -Change from Baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale after 28 days of treatment.
    -Change from Baseline in conjunctival hyperaemia scores based on the McMonnies scale after 28 days of treatment.
    -Variazione dallo standard di riferimento dei punteggi sulla scala analogica visiva (VAS) per
    fastidio/dolore oculare dopo 28 giorni di trattamento.
    -Variazione dallo standard di riferimento dei punteggi totali di colorazione corneale con fluoresceina (CFS)
    ottenuti sulla scala Oxford dopo 28 giorni di trattamento.
    -Variazione dallo standard di riferimento dei punteggi di iperemia congiuntivale sulla scala di McMonnies dopo 28 giorni di
    trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 giorni
    E.5.2Secondary end point(s)
    -Change from baseline in VAS scores for
    eye discomfort/pain at Day 14.
    -Change from baseline in each of the scores of the dry eye symptoms index (DESI) after 14 and 28 days of treatment.
    -Change from baseline in CFS total scores obtained on the Oxford scale ater 14 days of treatment.
    -Change from baseline in CFS central, nasal, temporal, superior and inferior scoring after 14 and 28 days of treatment.
    -Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale after 14 days of treatment.
    -Change from baseline in Tear break-up lime (TBUT) and conjunctival staining scores after 14 and 28 days of treatment.
    -Change from baseline in Schirmer's tests values at Days 14 and 28.
    -Number of artificial tears drops per day.
    -Assessment of the impact of treatment on the QoL (NEI-VFQ) questionnaire at Day 28.
    -Assessment of the impact of treatment on local and systemic tolerability.
    -Assessment of other Adverse Events (AEs) occurrence.
    -Variazione dallo standard di riferimento dei punteggi VAS per fastidio/dolore oculare al giorno 14.
    -Variazione dallo standard di riferimento di ciascun punteggio dell'indice dei sintomi per secchezza oculare (DESI) dopo 14 e 28
    giorni di trattamento.
    -Variazione dallo standard di riferimento dei punteggi totali di CFS ottenuti sulla scala Oxford dopo 14 giorni di trattamento.
    -Variazione dallo standard di riferimento dei punteggi CFS centrale, nasale, temporale, superiore e inferiore dopo 14 e 28 giorni di
    trattamento.
    -Variazione dallo standard di riferimento dei punteggi di iperemia congiuntivale sulla scala di McMonnies dopo 14 giorni di
    trattamento.
    -Variazione dallo standard di riferimento dei punteggi del tempo di rottura del film lacrimale (TBUT) e della colorazione
    congiuntivale dopo 14 e 28 giorni di
    trattamento.
    -Variazione dallo standard di riferimento dei valori del test di Schirmer ai giorni 14 e 28.
    -Numero di lacrime artificiali al giorno.
    -Questionario (NEI-VFQ) sulla valutazione dell'impatto del trattamento sulla qualità della vita (QoL) al giorno 28.
    -Valutazione dell'impatto del trattamento sulla tollerabilità sistemica e locale.
    -Valutazione degli eventi avversi (EA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14 and Day 28
    Throughout the study for tolerability and Adverse Events.
    Giorno 14 e 28.
    Durante tutto lo studio per la tollerabilità e gli eventi avversi.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Usual therapy described by specialist
    Terapia usuale descritta da un medico specialista
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
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