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    Summary
    EudraCT Number:2012-001177-93
    Sponsor's Protocol Code Number:SYL1001_II
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-001177-93
    A.3Full title of the trial
    PILOT TRIAL FOR ASSESSMENT TOLERABILITY AND EFFECT OF SYL1001 IN PATIENS WITH OCULAR PAIN
    ENSAYO PILOTO PARA EVALUAR LA SEGURIDAD Y EL EFECTO DE SYL1001 EN PACIENTES CON DOLOR OCULAR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASSESSMENT TRIAL OF THE EFFECT OF SYL1001 DRUG IN PATIENTS WITH OCULAR PAIN
    VALORACIÓN DEL EFECTO DEL MEDICAMENTO SYL1001 EN PACIENTES CON DOLOR OCULAR
    A.3.2Name or abbreviated title of the trial where available
    DOLOR OCULAR
    A.4.1Sponsor's protocol code numberSYL1001_II
    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
    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
    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 pointVerónica Ruz
    B.5.3 Address:
    B.5.3.1Street AddressParque Tecnológico de Madrid C/Santiago Grisolía nº 2
    B.5.3.2Town/ cityTres Cantos
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number918063188
    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
    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.3.9.2Current sponsor codeSYL1001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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
    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
    PATIENTS WITH DIAGNOSIS OF OCULAR PAIN MILD TO MODERATE AND DRY EYE MILD TO MODERATE
    PACIENTES OCN DIAGNÓATICO DE OJO SECO DE LEVE A MODERADO Y DOLOR OCULAR DE LEVE A MODERADO. SE EVALUARÁ EL EFECTO ANALGÉSICO ASÍ COMO LA TOLERABILIDAD LOCAL
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH DIAGNOSIS OF OCULAR PAIN MILD TO MODERATE AND DRY EYE MILD TO MODERATE
    PACIENTES OCN DIAGNÓATICO DE OJO SECO DE LEVE A MODERADO Y DOLOR OCULAR DE LEVE A MODERADO. SE EVALUARÁ EL EFECTO ANALGÉSICO ASÍ COMO LA TOLERABILIDAD LOCAL
    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
    ANALGESIC EFFECT AND TOLERABILITY OF SYL1001 IN PATIENTS WITH DRY EYE AND OCULAR PAIN
    DETERMINAR EL EFECTO ANALGÉSICO Y LA TOLERABILIDAD DE SYL1001EN PACIENTES DE OJO SECO Y DOLOR OCULAR
    E.2.2Secondary objectives of the trial
    Ocular tolerability
    SAE assessment
    Analytical parameters
    Evaluar la tolerancia general:
    -Evaluación de tolerancia ocular (resto de parámetros oculares determinados)
    -Evaluación de la aparición de AA.
    -Parámetros analíticos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    NA
    Los pacientes deberán cumplir todos los criterios de inclusión detallados a continuación para poder participar en el estudio:
    -Pacientes de ambos sexos.
    - 18 años de edad.
    -Haber otorgado por escrito su consentimiento para participar en el estudio, después de haber recibido toda la información sobre el mismo relativa al diseño, objetivos y posibles riesgos que de él se deriven.
    -Síntomas habituales de ojo seco, de leve a moderados de forma persistente y diaria durante más de tres meses.
    -Escala OSDI entre 13-30
    -Escala EVA. Registro de dolor de leve a moderado (2-7)
    -Pruebas oculares en los dos ojos (se consideran válidos los resultados obtenidos hasta 30 días antes de la inclusión):
    -Tinción corneal con fluoresceína. Escala Oxford > 0
    -Tiempo de rotura de la lágrima (BUT) < 10 segundos
    -Test de Schirmer con anestésico < 10 mm/5min
    E.4Principal exclusion criteria
    NA
    ?Mujeres embarazadas o en período de lactancia o test de embarazo en orina positivo. Mujeres que no se comprometan a seguir un método anticonceptivo médicamente aceptable desde la selección y durante todo el estudio.
    ?Cualquier enfermedad relevante actual, incluyendo enfermedad respiratoria, cardiovascular, endocrina, neurológica, hematológica, renal, oncológica, hepatopatía, disfunción gastrointestinal, hipertensión o procesos infecciosos agudos activos.
    ?Procesos crónicos o recurrentes previos que a juicio del investigador pudieran influir en el desarrollo del estudio.
    ?Utilización concomitante de otros medicamentos con actividad analgésica por cualquier vía de administración en el momento de entrada en el estudio.
    ?Cambio en cualquier medicación concomitante ocular y/o sistémica del paciente un mes antes del estudio y durante el mismo.
    ?Cambios en la pauta preestablecida de administración de lágrimas artificiales siempre durante los 15 días anteriores y los 10 días que dura el estudio.
    ?Inicio de tratamiento con ciclosporina o cambios en la posología o pauta de administración de ciclosporina en los 6 meses anteriores a la inclusión en el estudio.
    ?Antecedentes de hipersensibilidad a fármacos.
    ?Uso de lentillas durante el tratamiento y los 15 días anteriores.
    ?Antecedentes de abuso o dependencia a fármacos o alcohol.
    ?Alteraciones analíticas clínicamente relevantes, en opinión del investigador.
    ?Cirugía refractiva previa.
    ?Haber participado en otro ensayo clínico en los 2 meses previos a la inclusión.
    ?Otra patología ocular relevante a juicio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    NA
    Evaluación del efecto analgésico sobre el dolor ocular
    Mediante la utilización de cuestionarios y escalas validados, concretamente:
    -cuestionario OSDI (Ocular Surface Disease Index) © Allergan Inc, antes y tras finalizar el tratamiento
    -EVA (Evaluación Visual Analógica)
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    COMPARAR BASAL Y TRAS FINALIZAR EL TRATAMIENTO
    E.5.2Secondary end point(s)
    NA
    Otros parámetros de seguridad serán:
    -Exploración anterior del ojo.
    -PIO
    -Agudeza visual.
    -BUT
    -Test de Schrimer
    -Examen clínico, incluyendo exploración física, pruebas analíticas sanguíneas y urinarias.
    -Evaluación de la aparición de AA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    COMPARAR BASAL Y TRAS FINALIZAR EL TRATAMIENTO
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    NA
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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.4.2.2In the whole clinical trial 60
    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 habitual prescrita por especialista
    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 Decision2012-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
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