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    Summary
    EudraCT Number:2019-000982-19
    Sponsor's Protocol Code Number:IOBA-ImmunEyez_011-2018
    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:2019-10-21
    Trial 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 number2019-000982-19
    A.3Full title of the trial
    A Phase IV Open-Label Clinical Trial to Evaluate the Efficacy of Ikervis® on Clinical Parameters and Molecular/Cellular Biomarkers in Dry Eye Patients with Severe Keratitis who have not improved despite regular use of tear substitutes before and after Exposure to an Adverse Controlled Environment
    Ensayo clínico abierto fase IV para evaluar la eficacia de Ikervis® en parámetros clínicos y biomarcadores moleculares/celulares en pacientes con queratitis grave que no han mejorado a pesar del uso regular de sustitutos de lágrimas artificiales antes y después de la exposición a un entorno controlado adverso.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IV Open-Label Clinical Trial to Evaluate the Efficacy of Ikervis® on Clinical Parameters and Molecular/Cellular Biomarkers in Dry Eye Patients with Severe Keratitis who have not improved despite regular use of tear substitutes before and after Exposure to an Adverse Controlled Environment
    Ensayo clínico abierto fase IV para evaluar la eficacia de Ikervis® en parámetros clínicos y biomarcadores moleculares/celulares en pacientes con queratitis grave que no han mejorado a pesar del uso regular de sustitutos de lágrimas artificiales antes y después de la exposición a un entorno controlado adverso.
    A.4.1Sponsor's protocol code numberIOBA-ImmunEyez_011-2018
    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 SponsorInstituto de Oftalmobiología Aplicada (IOBA)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto de Oftalmobiología Aplicada (IOBA)
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportSanten Switzerland SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Oftalmobiología Aplicada (IOBA)
    B.5.2Functional name of contact pointIOBA
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Belén 17
    B.5.3.2Town/ cityValladolid
    B.5.3.3Post code47011
    B.5.3.4CountrySpain
    B.5.6E-mailfjpintof@ioba.med.uva.es
    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 Yes
    D.2.1.1.1Trade name Ikervis
    D.2.1.1.2Name of the Marketing Authorisation holderSANTEN OY
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.4Pharmaceutical form Eye drops
    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 INNIKERVIS
    D.3.9.3Other descriptive nameCICLOSPORIN A
    D.3.9.4EV Substance CodeSUB129839
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dry eye disease with severe keratitis
    Síndrome de ojo seco con queratitis sevbera
    E.1.1.1Medical condition in easily understood language
    Severe dry eye disease
    Síndrome de ojo seco severo
    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
    To evaluate the general efficacy after 30 days (early onset of efficacy) and 90 days (known onset efficacy) of using the study treatment, by evaluation of symptoms, extensive clinical signs, and molecular/cellular biomarkers.
    Evaluar la eficacia tras 30 (eficacia temprana) y 90 (eficacia conocida) días de administración del tratamiento, evaluando tanto síntomas y signos clínicos, como biomarcadores moleculares y celulares.
    E.2.2Secondary objectives of the trial
    - To evaluate the response to 2 hr of low humidity and air flow exposure under the study treatment.
    - To find new potential biomarkers for the therapeutic efficacy of Ikervis.
    - Evaluar la respuesta de los participantes bajo tratamiento tras 2 horas de exposición a condiciones ambientales de baja humedad y flujo de aire.
    - Buscar potenciales biomarcadores de eficacia del tratamiento de estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years.
    - Diagnosis of DED with Severe Keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously.
    - Not stable (as defined by the two items below) under at least 2 months of constant and regular use of artificial tears (at least 4 drops a day)
    - Fluorescein corneal staining ≥ 2 (Oxford scale) in both eyes.
    - DEQ-5 > 6 points
    - Use of at least 4 times daily of an ocular artificial tears.
    - Any concomitant medication that may affect DED, ocular surface condition or vision, must have a start date at least 3 months prior to baseline and dosage is not expected to change during the study.
    - Best corrected visual acuity (BCVA) of at least 0.1 logMar at 6 meters with each eye.
    - Signature of written informed consent form and data protection form.
    - Edad > 18 años.
    - Diagnóstico de síndrome de ojo seco con queratitis severa que no haya mejorado tras el uso regular de lágrimas artificiales, al menos en los 2 meses previos a la realización del estudio.
    - Situación no estable (definida mediante los dos items que aparecen a continuación) tras al menos 2 meses de uso regular y contante de lágrimas artificiales (al menos 4 gotas al día).
    - Tinción corneal con fluoresceína ≥ 2 (escala Oxford) en ambos ojos.
    - DEQ-5 > 6 puntos.
    - Uso de lágrimas artificiales al menos 4 veces al día.
    - Cualquier medicación concomitante que pueda afectar al SOS, condición de la superficie ocular o visión, debe haber comenzado al menos 3 meses antes de la visita basal, y se espera que su dosis no cambiará durante el estudio.
    - Mejor agudeza visual corregida de al menos 0.1 logMar a 6 metros con cada ojo.
    - Firma del consentimiento informado y la cláusula de protección de datos.
    E.4Principal exclusion criteria
    - Known allergy or sensitivity to the study product(s) or its components.
    - Any ocular pathology other than DED.
    - History of severe ocular inflammation other than that due to DED or infection in the 6 previous months to the study inclusion.
    - Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months or any ocular or systemic surgery or procedure planned during the study duration that may affect the study as assessed by principal investigator.
    - History of refractive surgery in the previous 18 months.
    - Contact lens use in the ONE previous month to study inclusion and during the duration of the study.
    - Use of any ocular topical medication for pathologies other than DED.
    - Use of any other ocular topical medication for DED other than artificial tears during the last ONE (steroids) or THREE months (ciclosporine, tacrolimus) .
    - Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren’s syndrome)
    - The start date of any systemic medication that may affect DED, ocular surface condition or vision is < 3 months prior to baseline or a change in dosage is anticipated during the study.
    - Occlusion of the lacrimal puncta either surgically or with plugs within one month prior to study, or anticipated use of the same during the study.
    - Pregnancy or breastfeeding.
    - Current enrolments in an investigational drug or device study or participation in such a study within 30 day of entry into this study at baseline.
    - Alergia o sensibilidad conocida a cualquiera de los productos de estudio.
    - Cualquier otra patología ocular diferente a SOS.
    - Historia de inflamación ocular severa diferente a la causada por el SOS o infección en los 6 meses previos a la inclusión en el estudio.
    - Cualquier cirugía ocular o trauma ocular que pueda afectar a la sensibilidad corneal y/o la distribución normal de la lágrima en los 6 meses previos a la inclusión, o cualquier cirugía o procedimiento ocular o sistémico planificado durante la realización del estudio que pueda afectar al estudio según el criterio del investigador principal.
    - Historia de cirugía refractiva en los 18 meses previos al estudio.
    - Uso de lentes de contacto durante el mes previo a la inclusión en el estudio o durante la realización del mismo.
    - Uso de cualquier medicación tópica ocular para patologías diferentes al SOS.
    - Uso de cualquier medicación tópica ocular para el SOS diferente al las lágrima artificiales en el mes previo (en caso de esteróides) o en los 3 meses previos (en caso de ciclosporina o tracolimus).
    - Cualquier enfermedad sistémica grave no controlada que pueda afectar a los ojos (exceptuando el Síndrome de Sjögren).
    - Fecha de inicio de cualquier medicación sistémica que pueda afectar al SOS, el estado de la superficie ocular, o la visión < de 3 meses previos a la visita basal, o si se prevee un cambio durante el estudio en la dosis de dichos tratamientos.
    - Oclusión de los puntos lagrimales, tanto quirúrgicamente como mediante oclusores, dentro del mes previo al estudio, o previsión de su uso o realización durante el estudio.
    - Embarazo o lactancia.
    - Estar actualmente enrolado en otra investigación con medicamentos o dispositivos en investigación, o participación en estos estudios dentro de los 30 días anteriores a la visita de inclusión de este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Significant reduction in corneal fluorescein staining.
    Reducción significativa de la tinción corneal con fluoresceína.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - V1 (baseline) vs V2 (30 days of treatment).
    - V1 (baseline) vs V3 (90 days of treatment).
    - V2 (30 days of treatment) vs V3 (90 days of treatment).
    - V1 (basal) frente a V2 (30 días de tratamiento).
    - V1 (basal) frente a V3 (90 días de tratamiento).
    - V2 (30 días de tratamiento) frente a V3 (90 días de tratamiento).
    E.5.2Secondary end point(s)
    - Significant differences in the percentage of patients suffering a worsening in clinical signs and/or symptoms following exposure to adverse environmental conditions.
    - Significant reduction in median expression of HLA-DR by conjunctival epithelial cells.
    - Diferencias significativas en el porcentaje de pacientes que muestran un empeoramiento en los signos clínico y/o la sintomatología tras la exposición a condiciones ambientales adversas.
    - Reducción significativa de la expresión media de HLA-DR mediante estudio de células epiteliales conjuntivales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - V1 (baseline) vs V2 (30 días de tratamiento).
    - V1 (baseline) vs V3 (90 días de tratamiento).
    - V1 (basal) frente a V2 (30 days of treatment).
    - V1 (basal) frente a V3 (90 days of treatment).
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Última visita del último participante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    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)
    None
    Ninguno
    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 Decision2019-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-31
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