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    Summary
    EudraCT Number:2021-003373-64
    Sponsor's Protocol Code Number:01-DIMS-2021
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-27
    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 number2021-003373-64
    A.3Full title of the trial
    POST-MARKETING PARALLEL CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS AND TOLERABILITY OF DIMS LENSES IN THE CONTROL OF MYOPIA IN PEDIATRIC POPULATION
    ENSAYO CLÍNICO PARALELO POSTCOMERCIALIZACIÓN, COMPARATIVO CON TERAPIA ESTÁNDAR PARA DETERMINAR LA EFICACIA Y TOLERABILIDAD DE LENTES DIMS EN EL CONTROL DE LA MIOPÍA EN POBLACIÓN PEDIÁTRICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL WITH DIMS LENSES FOR THE CONTROL OF MYOPIA IN PEDIATRIC POPULATION
    ENSAYO CLINICO DE LENTES DIMS PARA EL CONTROL DE LA MIOPIA EN POBLACION PEDIATRICA
    A.4.1Sponsor's protocol code number01-DIMS-2021
    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 SponsorNOEMI GUEMES VILLAHOZ
    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 supportHOYA VISION
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL CLINICO SAN CARLOS
    B.5.2Functional name of contact pointSERVICIO DE OFTALMOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressPROFESOR MARTIN LAGOS S/N 1º PLANTA NORTE SERVICIO DE OFTALMOLOGIA
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.6E-mailnoemiguemes@gmail.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 Yes
    D.2.1.1.1Trade name COLIRCUSÍ ATROPINA 10 mg/ml colirio en solución
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Healthcare S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Ophthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATROPINE SULFATE
    D.3.9.1CAS number 55-48-1
    D.3.9.2Current sponsor codepr1
    D.3.9.4EV Substance CodeSUB00625MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.001
    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
    MYOPIA IN PEDIATRIC POPULATION
    MIOPIA EN POBLACION PEDIATRICA
    E.1.1.1Medical condition in easily understood language
    MYOPIA IN CHILDREN
    MIOPIA EN NIÑOS
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    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 know the efficacy and safety of the combined use of 0.01% diluted atropine eye drops and DIMS technology ophthalmic lenses in the control of myopia progression in the pediatric population
    Conocer la eficacia y seguridad del empleo combinado de colirio de atropina diluida 0.01% y lentes oftálmicas de tecnología DIMS en el control de la progresión de la miopía en población pediátrica.
    E.2.2Secondary objectives of the trial
    Know the tolerance of ophthalmic lenses with DIMS technology in myopic pediatric population
    Evaluate and measure the effect on the refractive state and axial length in each treatment group
    Conocer la tolerancia de lentes oftálmicas de tecnología DIMS en población pediátrica miope.
    Evaluar y medir el efecto en el estado refractivo y longitud axial en cada grupo de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients between 4-16 years of age.
    Informed consent signed by parents or guardians in all patients and patients between 12 and 16 years of age.
    Refractive defect: myopia greater than -1.00 diopters (D).
    Progression of myopia of at least -0.50 D in the last 12 months
    Astigmatism of 2 D or less and anisometropia of 1.50 D or less
    Monocular visual acuity (VA) best corrected of 0.2 logMAR (6/9) or better
    Pacientes entre 4-16 años de edad.
    Firma de consentimiento informado por parte de los padres o tutores en todos los pacientes y de pacientes entre 12 y 16 años
    Defecto refractivo: miopía mayor de -1,00 dioptrías (D).
    Progresión de la miopía de al menos -0.50 D en los últimos 12 meses
    Astigmatismo de 2 D o menos y anisometropía de 1.50 D o menos.
    Agudeza visual (AV) monocular mejor corregida de 0,2 logMAR(6/9) o mejor
    E.4Principal exclusion criteria
    Under 4 years old and over 16 years old
    Strabismus and binocular vision abnormalities
    Fundus with alterations that the investigator considers exclusive to participate in the study.
    Ocular pathology of the anterior segment (opacity of media such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision.
    Previous eye surgery
    amblyopia
    systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)
    Previous treatments for the control of myopia, including orthokeratology, rigid contact lenses, bifocal soft contact lenses or for the control of myopia, bifocal and multifocal ophthalmic lenses in the 3 months prior to the study.
    -Menores de 4 años y mayores de 16 años
    -Estrabismo y anomalías de la visión binocular.
    -Fondo de ojo con alteraciones que el investigador considere excluyentes para participar en el estudio.
    -Patología ocular del segmento anterior (opacidad de medios como cataratas, glaucoma, afaquia, pseudofaquia, uveítis, queratocono o alteraciones de superficie), y cualquier patología del segmento posterior que impida una correcta visión
    -Ambliopia
    -Cirugía ocular previa
    -Patología sistémica (patología cardiopulmonar, alteraciones del tejido conectivo, patología neurológica o psiquiátrica) o situación basal del paciente que no permita la realización de la exploración (como retraso mental o psicomotor)
    -Tratamientos previos para el control de la miopía, incluido ortoqueratología, lentes de contacto rígidas, lentes de contacto blandas bifocales o para el control de la miopía, lentes oftálmicos bifocales y multifocales en los 3 meses previos al estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Refractive defect after cycloplegia with 1% cyclopentolate 3 drops 10 minutes apart. Assessment after 30 minutes.
    Defecto refractivo tras cicloplejia con ciclopentolato al 1% 3 gotas separadas 10 minutos. Valoración tras 30 minutos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    primary end point will be evaluate every 6 month for 2 years
    se valorará la variable principal cada 6 meses, durante 2 años.
    E.5.2Secondary end point(s)
    Axial length in millimeters
    Choroidal and retinal thickness measured in Optical Coherence Tomography (OCT) in m
    Intraocular pressure in mmHg
    Longitud axial en milímetros
    Grosor coroideo y retiniano medido en Tomografía de coherencia óptica (OCT) en m
    • Presión intraocular en mmHg
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 ,12 ,18, 24 months
    3, 6 ,12 ,18, 24 meses
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    lentes monofocales y LENTES de desenfoque periférico (tecnología DIMS)
    single vision lenses and Peripheral Blur LENSES (DIMS Technology)
    E.8.2.4Number of treatment arms in the trial2
    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
    at the end of the 24-month treatment of the last patient included in the study
    al finalizar el tratamiento de 24 meses del ultimo paciente incluido en el estudio
    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 Yes
    F.1.1Number of subjects for this age range: 50
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state50
    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
    NO
    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 Decision2021-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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