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    Summary
    EudraCT Number:2016-003903-79
    Sponsor's Protocol Code Number:SYL1001_IV
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-02
    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 ConcernedPortugal - INFARMED
    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)
    Estudo duplo-cego do SYL1001 em doentes com doença do olho seco (DED) moderada 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
    Estudo duplo-cego do SYL1001 em doentes com doença do olho seco moderada a grave
    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 SAU - PharmaMar Group
    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 - ParmaMar Group
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSylentis
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressPTM - C/Santiago Grisolia n°2
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491906 31 88
    B.5.5Fax number+3491804 95 97
    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.2.5The 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 in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSYL1001
    D.3.9.1CAS number 1848239-71-3
    D.3.9.2Current sponsor codeSYL1001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 in single-dose container
    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)
    Doença do olho seco (DED) moderada a grave
    E.1.1.1Medical condition in easily understood language
    Moderate to severe dry eye
    Doença do olho seco moderada a grave
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013774
    E.1.2Term Dry eye
    E.1.2System Organ Class 10015919 - Eye disorders
    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
    Avaliar a eficácia do SYL1001 a 11,25 mg/mL nos sinais e sintomas da DED
    E.2.2Secondary objectives of the trial
    Safety assessment : local and systemic tolerability, and Adverse Events
    Avaliação de segurança: Tolerabilidade local e sistémica, e Efeitos Adversos
    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. O doente é uma pessoa do sexo masculino ou feminino com idade ≥ 18 anos na consulta de triagem.
    2. Conceder autorização por escrito para participar no estudo, depois de receber todas as informações relacionadas com a conceção, os objetivos e os possíveis riscos resultantes.
    3. Os sintomas comuns de olho seco persistente, diário, moderado a severo duram mais de seis meses.
    4. Utilização de lágrimas artificiais durante os últimos 30 dias antes da fase de seleção.
    5. Escala VAS relativa a desconforto/dor entre 30 – 80 em um dos olhos e pelo menos ≥ 20 no outro olho.
    6. CFS ≥ 2 e ≤ 4 na escala de Oxford (0-5) em pelo menos 1 região do olho com a classificação VAS mais elevada relativamente a desconforto/dor no olho.
    7. TBUT < 10 segundos no olho com a classificação VAS mais elevada relativamente a desconforto/dor no olho. TBUT ≥ 1 em ambos os olhos.
    8. Classificação de hiperemia ≥ 1 (escala de McMonnies) no olho com a classificação VAS mais elevada relativamente a desconforto/dor no olho.
    9. Teste de Schirmer sem anestesia ≥ 2 e < 10 mm/5 min. no olho com a classificação VAS mais elevada relativamente a desconforto/dor no olho. Valor ≥ 2 no outro olho.
    10. Acuidade visual corrigida ≤ 0,7 logMAR (≥ 20/100 Snellen ou ≥ 50 ETDRS) em ambos os olhos.
    11. Se o sujeito for selecionado em França, tem de estar coberto por um Sistema de segurança social nacional aquando da consulta de triagem.
    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 from enrolment until after the final visit. Medically acceptable contraceptive methods include vasectomised sexual partner, bilateral tubal ligation, intrauterine devices or implants, normal or low dose combination oral pills, injectable contraceptive, ethinylestradiol transdermal system intravaginal devices and documented use of condoms. True sexual abstinence (starting from enrollment until after the follow-up visit) is also an acceptable contraceptive method.
    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 presence of punctal 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) history of recurrent corneal herpes or history of recurrent corneal erosion or neurotrophic keratopathy (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 participated in SYL1001_IV trial.
    15. Non-compliance after the run-in period.
    1. Mulheres grávidas, a amamentar ou com um teste de gravidez positivo aquando da consulta de triagem.
    2. Mulheres em idade fértil que não estejam dispostas a usar um método contracetivo aceitável do ponto de vista clínico (definição na secção 6.3) desde a inscrição até depois da visita final.
    3. Doenças atuais, anteriormente crónicas ou recorrentes que, de acordo com o investigador, possam ser impacto na interpretação dos resultados do estudo ou colocar o sujeito em risco.
    4. Utilização atual de qualquer medicação concomitante com atividade analgésica (tais como utilizadores regulares de analgésicos) por qualquer via de administração aquando da entrada no estudo e durante o mesmo.
    5. Alteração da medicação concomitante sistémica um mês antes do estudo e durante o mesmo que possa ter impacto sobre a interpretação dos resultados de acordo com o investigador.
    6. Tratamento concomitante com ciclosporina, tacrolímus, sirolímus (sistémico ou oftálmico) durante os 2 meses antes de entrar no estudo.
    7. Qualquer tratamento concomitante ocular aquando da entrada no estudo. As lágrimas artificiais não conservadas serão fornecidas pelo Promotor para utilização ao longo do estudo. São permitidas no máximo 4 gotas por dia.
    8. Historial de hipersensibilidade ao SYL1001, a qualquer componente da formulação ou a agentes de diagnóstico oftálmicos.
    9. Utilização de lentes de contacto ou presença de tampões lacrimais durante o tratamento e os 7 dias anteriores (antes do início do tratamento).
    10. Anomalias laboratoriais clinicamente significativas de acordo com a opinião do investigador
    11. Cirurgia refrativa anterior, transplante corneano. Disfunção da glândula meibomiana ou historial de posicionamento incorreto da pálpebra (ectrópio, entrópio, ptose), historial de herpes corneana recorrente ou historial de erosão corneana recorrente ou queratopatia neurotrófica (que pode afetar a avaliação precisa da doença e/ou ocultar os efeitos do medicamento)
    12. Qualquer outra cirurgia ocular decorrida no período de 1 ano.
    13. Qualquer outra doença ocular significativa na opinião do investigador.
    14. A participar ou tendo participado noutro ensaio clínico no espaço de 2 meses antes da inclusão. Doente que já participou no ensaio SYL1001_IV.
    15. Não conformidade após o período de preparação.
    E.5 End points
    E.5.1Primary end point(s)
    o Change from Baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain after 28 days of treatment
    o Change from Baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale after 28 days of treatment
    o Change from Baseline in conjunctival hyperaemia scores based on the McMonnies scale after 28 days of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    o Change from baseline in VAS scores for eye discomfort/pain at Day 14
    o Change from baseline in each of the scores of the dry eye symptoms index (DESI) after 14 and 28 days of treatment
    o Change from baseline in CFS total scores obtained on the Oxford scale ater 14 days of treatment
    o Change from baseline in CFS central, nasal, temporal, superior and inferior scoring after 14 and 28 days of treatment
    o Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale after 14 days of treatment
    o Change from baseline in Tear break-up lime (TBUT) and conjunctival staining scores after 14 and 28 days of treatment
    o Change from baseline in Schirmer's tests values at Days 14 and 28.
    o Number of artificial tears drops per day
    o Assessment of the impact of treatment on the QoL (NEI-VFQ) questionnaire at Day 28.
    o Assessment of the impact of treatment on the Clinical Global Impression Questionnaires (Clinician and Subject) at Day 28.
    o Assessment of the impact of treatment on local and systemic tolerability.
    o Assessment of other Adverse Events (AEs) occurrence
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14 and Day 28
    Throughout the study for tolerability and Adverse Events
    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 concerned3
    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
    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 state80
    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
    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 Decision2017-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-16
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