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    Summary
    EudraCT Number:2021-006801-31
    Sponsor's Protocol Code Number:01-INSULINAOJOSECO-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:2022-03-18
    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 number2021-006801-31
    A.3Full title of the trial
    RANDOMIZED PARALLEL CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS AND SAFETY OF TOPICAL INSULIN IN THE TREATMENT OF DRY EYE IN PATIENTS WITH DRY EYE
    ENSAYO CLÍNICO ALEATORIZADO PARALELO PARA DETERMINAR LA EFICACIA Y SEGURIDAD DEL COLIRIO DE INSULINA EN EL TRATAMIENTO DEL OJO SECO EN PACIENTES CON OJO SECO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS AND SAFETY OF TOPICAL INSULIN IN THE TREATMENT OF DRY EYE I
    ENSAYO CLÍNICO PARA DETERMINAR LA EFICACIA Y SEGURIDAD DEL COLIRIO DE INSULINA EN EL TRATAMIENTO DEL OJO SECO
    A.4.1Sponsor's protocol code number01-INSULINAOJOSECO-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 SponsorBarbara Burgos-Blasco
    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 supportHospital Clinico San Carlos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBarbara Burgos-Blasco
    B.5.2Functional name of contact pointBarbara Burgos-Blasco
    B.5.3 Address:
    B.5.3.1Street AddressC/ profesor martin lagos s/n
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913303132
    B.5.5Fax number+34913303515
    B.5.6E-mailbarbara.burgos@salud.madrid.org
    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 Actrapid
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinsulina
    D.3.9.1CAS number 9004-10-8
    D.3.9.2Current sponsor codeinsulina
    D.3.9.3Other descriptive nameINSULIN
    D.3.9.4EV Substance CodeSUB02689MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(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.IMP: 2
    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 CICLOSPORINA A
    D.2.1.1.2Name of the Marketing Authorisation holderAcofarma
    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
    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 INNOL-27400
    D.3.9.1CAS number OL-27400
    D.3.9.2Current sponsor codeOL-27400
    D.3.9.3Other descriptive nameCICLOSPORIN A
    D.3.9.4EV Substance CodeSUB129839
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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
    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
    Dry eye disease
    Enfermedad del ojo seco
    E.1.1.1Medical condition in easily understood language
    Dry eye disease
    Ojo seco
    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 investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease
    Conocer la eficacia y seguridad del empleo de colirio de insulina en el control de la enfermedad de ojo seco moderada-grave
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Patients older than 18 years
     Signed informed consent by the patient
     Corneal staining equal to or greater than Oxford II
     OSDI greater than 12
     Treatment with artificial tears or hyaluronic acid gels for at least 3 months
     Pacientes mayores de 18 años
     Firma del consentimiento informado por parte del paciente
     Tinción corneal igual o mayor a Oxford II
     OSDI mayor de 12
     Tratamiento con lágrima artificial y/o gel de ácido hialurónico durante al menos 3 meses
    E.4Principal exclusion criteria
     Under 18 years old
     Corneal staining under Oxford II
     OSDI below 13
     Changes in topical treatment in the last 3 months
     Eye surgery in the last 6 months
     Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations
     Contact lenses
     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)
     Other treatment besides artificial tears or hyaluronic acid gels
     Visual acuity less than 0.1
     Allergy or intolerance to any of the components included in the study
     Modifications in systemic immunosuppressive treatment
     Pregnancy or lactation
     Women of childbearing age who do not use a highly effective contraceptive method
     History of alcohol or drug abuse
     Participation in another clinical trial in the last 30 days
     Menores de 18 años
     Tinción corneal menor de Oxford II
     OSDI menor de 13
     Cambios en el tratamiento tópico en los últimos 3 meses
     Cirugía ocular en los últimos 6 meses
     Otra patología corneal concomitante, malposición palpebral, alteraciones del drenaje nasolagrimal, alteraciones del parpadeo
     Uso de lentes de contacto
     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)
     Otro tratamiento distinto de lágrima artificial y/o gel de ácido hialurónico
     Agudeza visual menor de 0.1
     Alergia o intolerancia a alguno de los componentes incluidos en el estudio
     Modificaciones en el tratamiento inmunosupresor sistémico
     Embarazo o lactancia
     Mujeres en edad fértil que no empleen un método anticonceptivo de alta efectividad
     Antecedentes de abuso de alcohol o drogas
     Participación en otro ensayo clínico en los últimos 30 días
    E.5 End points
    E.5.1Primary end point(s)
    No corneal staining
    No tinción corneal
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 3 and 6 months after starting treatment
    1, 3 y 6 meses tras iniciar tratamiento
    E.5.2Secondary end point(s)
    Improvement in dry eye symptoms, esthesiometry, and tear rupture time
    Mejoría en los síntomas de ojo seco, estesiometría y el tiempo de ruptura lagrimal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3 and 6 months after starting treatment
    1, 3 y 6 meses tras iniciar 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lágrima artificial
    Artificial tears
    E.8.2.4Number of treatment arms in the trial3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 80
    F.1.3Elderly (>=65 years) No
    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 state120
    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
    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 Decision2022-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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