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    Summary
    EudraCT Number:2022-002434-13
    Sponsor's Protocol Code Number:01-INSULINAGLAUCOMA-2022
    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:2022-08-02
    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 number2022-002434-13
    A.3Full title of the trial
    RANDOMIZED CLINICAL TRIAL DOUBLE BLIND (WITH BLIND EVALUATOR) TO DETERMINE THE EFFECTIVENESS AND SAFETY OF TOPICAL INSULIN IN THE TREATMENT OF DRY EYE IN PATIENTS WITH TOPICAL HYPOTENSIVE DRUGS
    ENSAYO CLÍNICO ALEATORIZADO, DOBLE CIEGO (CON EVALUADOR CIEGO), PARALELO, PARA DETERMINAR LA EFICACIA Y SEGURIDAD DEL COLIRIO DE INSULINA EN EL TRATAMIENTO DEL OJO SECO EN PACIENTES CON HIPOTENSORES TÓPICOS
    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 IN GLAUCOMA
    ENSAYO CLÍNICO PARA DETERMINAR LA EFICACIA Y SEGURIDAD DEL COLIRIO DE INSULINA EN EL TRATAMIENTO DEL OJO SECO EN GLAUCOMA
    A.4.1Sponsor's protocol code number01-INSULINAGLAUCOMA-2022
    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.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 in glaucoma
    Enfermedad del ojo seco en el glaucoma
    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 evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensives, compared to placebo (artificial tears) measured as changes in symptoms measured by the OSDI questionnaire at 6 months.
    Evaluar la eficacia preliminar del empleo de colirio de insulina en el control de la enfermedad de ojo seco en pacientes con hipotensores tópicos, en comparación con placebo (lágrima artificial) medido como cambios en los síntomas medidos mediante el cuestionario OSDI a los 6 meses.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensives, compared to placebo (artificial tears) measured as changes in corneal staining (Oxford scale), light scattering analysis , corneal esthesiometry, NITBUT, conjunctival hyperemia, tear cytokine concentrations, and compliance with topical hypotensive treatment at 6 months.
    - To evaluate the safety of the use of insulin eye drops in the control of dry eye disease in patients with glaucoma, measured as the frequency, type and severity of adverse effects at 6 months.
    - Evaluar la eficacia del empleo del colirio de insulina en el control de la enfermedad de ojo seco en pacientes con hipotensores tópicos, en comparación con placebo (lágrima artificial) medido como cambios en la tinción corneal (escala Oxford), análisis de dispersión de luz, la estesiometría corneal, el NITBUT, la hiperemia conjuntival, las concentraciones de citoquinas en la lágrima y el cumplimiento del tratamiento hipotensor tópico a los 6 meses.
    - Evaluar la seguridad del empleo de colirio de insulina en el control de la enfermedad de ojo seco en pacientes con glaucoma, medido como la frecuencia, tipo y severidad de los efectos adversos a los 6 meses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who give their informed written consent and who are able and willing to comply with all scheduled study visits and procedures.
    2. Patients ≥ 18 years old at the screening visit.
    3. Ocular hypertension or glaucoma controlled with hypotensive treatment
    4. Diagnosis of dry eye
    1. Pacientes que otorguen su consentimiento informado por escrito y que sean capaces y estén dispuestos a cumplir con todas las visitas y procedimientos programados del estudio.
    2. Pacientes ≥ 18 años en la visita de selección.
    3. Hipertensión ocular o glaucoma controlado con tratamiento hipotensor
    4. Diagnóstico de ojo seco
    E.4Principal exclusion criteria
    1. Uncontrolled glaucoma with expected changes in hypotensive treatment in the next 6 months
    2. Changes in topical glaucoma treatment in the last 3 months
    3. Dry eye treatment containing preservatives in the last 3 months
    4. Severe dry eye requiring immediate treatment
    5. Previous eye surgery, except cataract surgery more than 12 months ago
    6. Laser procedures less than 6 months ago
    7. Other concomitant ocular pathology: scarring of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days
    8. Palpebral alterations: palpebral malposition, nasolacrimal drainage alterations or blinking alterations
    9. Use of contact lenses
    10. Other topical treatment other than dry eye and glaucoma
    11. Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
    12. Changes in systemic immunosuppressive treatment in the last 6 months
    13. History of alcohol or drug abuse
    14. Patients who have received an experimental drug or used an experimental medical device within 30 days prior to the screening visit.
    15. Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline condition of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation).
    16. Any other disease or condition that, in the investigator's opinion, could constitute a risk for the participant or interfere with the results of the study.
    1. Glaucoma no controlado con cambios esperables en el tratamiento hipotensor en los próximos 6 meses
    2. Cambios en el tratamiento tópico de glaucoma en los últimos 3 meses
    3. Tratamiento para el ojo seco que contenga conservantes en los últimos 3 meses
    4. Ojo seco grave que necesite tratamiento inmediato
    5. Cirugía ocular previa, excepto cirugía de catarata hace más de 12 meses
    6. Procedimientos láser hace menos de 6 meses
    7. Otra patología ocular concomitante: patología cicatricial de la superficie ocular, uveítis, infección en los últimos 90 días, traumatismo en los últimos 90 días
    8. Alteraciones palpebrales: malposición palpebral, alteraciones del drenaje nasolagrimal o alteraciones del parpadeo
    9. Uso de lentes de contacto
    10. Otro tratamiento tópico distinto del ojo seco y el glaucoma
    11. Pacientes con antecedentes de alergia o hipersensibilidad a la medicación del estudio o a alguno de sus excipientes
    12. Modificaciones en el tratamiento inmunosupresor sistémico en los últimos 6 meses
    13. Antecedentes de abuso de alcohol o drogas
    14. Pacientes que hayan recibido un fármaco experimental o usado un dispositivo médico experimental en un periodo de 30 días antes de la visita de selección.
    15. 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).
    16. Cualquier otra enfermedad o condición que, a criterio del investigador, pudiera constituir un riesgo para el participante o interferir con los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change in OSDI questionnaire score, relative to baseline values
    Cambio en la puntuación del cuestionario OSDI, en relación con los valores basales
    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)
    Efficacy evaluation:
    - Change in corneal staining measured by the Oxford scale, relative to baseline (measured on slit-lamp photographs of the cornea by a blinded assessor)
    - Change in corneal esthesiometry, in relation to baseline values
    - Change in NITBUT (tear break-up time and therefore objectively measures tear stability) measured by Keratograph, in relation to baseline values
    - Change in conjunctival hyperemia measured by Keratograph, relative to baseline values
    - Changes in light scattering relative to baseline values
    - Change in tear cytokine concentrations measured by ELISA, relative to baseline values
    - Changes in therapeutic compliance with hypotensive treatment measured as a patient questionnaire (Medication adherence rating scale)

    Safety evaluation:
    Proportion of patients with adverse effects
    Evaluación de eficacia:
    - Cambio en la tinción corneal medido mediante la escala Oxford, en relación con los valores basales (medida en fotografías de la córnea en lámpara de hendidura por un evaluador ciego)
    - Cambio en la estesiometría corneal, en relación con los valores basales
    - Cambio en el NITBUT (tiempo de ruptura lagrimal y por tanto mide objetivamente la estabilidad de la lágrima) medido por Keratograph, en relación con los valores basales
    - Cambio en la hiperemia conjuntival medida por Keratograph, en relación con los valores basales
    - Cambios en la dispersión de luz en relación con los valores basales
    - Cambio en las concentraciones de citoquinas en la lágrima medidas mediante ELISA, en relación con los valores basales
    - Cambios en el cumplimiento terapéutico del tratamiento hipotensor medido como cuestionario al paciente (Medication adherence rating scale)

    Evaluación de seguridad:
    Proporción de pacientes que presenten efectos adversos
    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 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 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 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
    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: 100
    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 state100
    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 Decision2023-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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