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    Summary
    EudraCT Number:2015-000937-54
    Sponsor's Protocol Code Number:MC2-03-C1
    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:2015-09-01
    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 number2015-000937-54
    A.3Full title of the trial
    A phase II, multicenter, randomized, double-masked, 4 parallel arms, controlled 6-month trial designed to evaluate the safety and efficacy of PAD ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy and a 3-month post-treatment safety follow-up in moderate to severe dry eye patients
    Una fase II, multicéntrico, aleatorizado, con enmascaramiento doble, de 4 grupos paralelos, controlado y de 6 meses de duración para evaluar la seguridad y la eficacia de una dispersión oftálmica de ciclosporina PAD (CsA 0,06 % y 0,03 %) administrada una vez al día en combinación con terapia lubricante y seguimiento de la seguridad de tres meses tras el tratamiento en pacientes con xeroftalmía entre moderada y grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the safety and efficacy of PAD ciclosporin in dry eye patients
    A.4.1Sponsor's protocol code numberMC2-03-C1
    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 SponsorDRUG DELIVERY SOLUTIONS ApS (PART OF MC2 BIOTEK GROUP)
    B.1.3.4CountryDenmark
    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 supportDRUG DELIVERY SOLUTIONS ApS (PART OF MC2 BIOTEK GROUP)
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFarmajobconsult
    B.5.2Functional name of contact pointPaloma Ramirez
    B.5.3 Address:
    B.5.3.1Street AddressValle de Arán, 6. Villafranca del Castillo
    B.5.3.2Town/ city Madrid
    B.5.3.3Post code28692
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 815 13 07
    B.5.6E-mailpalomaramirez@farmajobconsult.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 namePADciclo 0.06%
    D.3.4Pharmaceutical form Eye drops, emulsion
    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 INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.060
    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 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 namePADciclo 0.03%
    D.3.4Pharmaceutical form Eye drops, emulsion
    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 INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.030
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.2Name of the Marketing Authorisation holderMoorfields Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code Best Standard Care (Lubricant therapy)
    D.3.4Pharmaceutical form Eye drops, solution in single-dose container
    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 INNHypromellose
    D.3.9.1CAS number 0009004-65-3
    D.3.9.3Other descriptive nameMETHYL HYDROXYPROPYL CELLULOSE
    D.3.9.4EV Substance CodeSUB02622MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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 Yes
    D.3.11.13.1Other medicinal product typeHydromoor is classified as a medical device (eyedrops classified as a medical device).
    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, emulsion
    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
    ocular dryness (Dry Eye Disease - DED)
    sequedad ocular (enfermedad del ojo seco)
    E.1.1.1Medical condition in easily understood language
    dry eye
    ojo seco
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10013778
    E.1.2Term Dry eyes
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10013777
    E.1.2Term Dry eye syndrome
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to:
    1. Evaluate the ocular tolerance and overall ocular safety of PADciclo (0.06% and 0.03%) in dry eye patients.
    2. Evaluate the efficacy of PADciclo (0.06% and/or 0.03%) compared to current BSC administered once daily for 6 months in improving CFS in dry eye patients using a responder approach analysis.
    Los objetivos principales de este estudio son:
    1. evaluar la tolerancia ocular y la seguridad ocular general de PADciclo™ (al 0,06 y al 0,03 %) en pacientes con xeroftalmía;
    2. evaluar la eficacia de PADciclo™ (al 0,06 o al 0,03 %) en comparación con los MCP actuales, administrados una vez al día durante seis meses, respecto a la mejora de la TCF en los pacientes con xeroftalmía usando un análisis centrado en el paciente que responde al tratamiento.
    E.2.2Secondary objectives of the trial
    The key secondary study objective is to:
    Evaluate the efficacy of PADciclo (0.06% and 0.03%) to current BSC administered once daily for 6 months in improving corneal fluorescein staining and global ocular discomfort score (VAS) in dry eye patients using a composite responder approach analysis.
    El principal objetivo secundario del estudio es:
    Evaluar la eficacia de PADciclo™ (al 0,06 y al 0,03 %) en comparación con los MCP actuales administrados una vez al día
    durante seis meses respecto a la mejora de la tintinó corneal con fluoresceína y la puntuación (EVA) de molestia ocular
    global en los pacientes con xeroftalmía usando un análisis compuesto centrado en el paciente que responde al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients are at least 18 years of age
    2. Patients with at least a 3 month documented history of moderate to severe DED persisting despite conventional management (which may include artificial tear drops, gels, ointments and/or punctual occlusion), and defined as the following:
    a. Corneal fluorescein staining (CFS) = 3 or 4 (modified Oxford scale, scale 0 – 5)
    AND
    b. Global ocular discomfort score of ≥ 30mm using a 100 mm VAS. Patients will assess burning/stinging, foreign body sensation, eye dryness and pain and the mean score will be calculated: (where "0" means no symptom and "100" means the worst that have ever experienced).
    3. Patients must provide written informed consent
    4. Patients must be willing and able to undergo and return for scheduled study-related examinations.
    1. Los pacientes deben tener al menos 18 años.
    2. Pacientes con antecedentes documentados de al menos tres meses de xeroftalmía entre moderada e intensa que persiste a pesar de recibir el tratamiento convencional (que puede incluir lágrimas artificiales, geles, ungüentos u oclusión puntal) y definidos de la siguiente forma:
    a. tinción corneal con fluoresceína (TCF) = 3 o 4 (escala de Oxford modificada, 0-5);
    Y
    b. puntuación de molestia ocular global de ≥ 30 mm usando una EVA de 100 mm. Los pacientes evaluarán la quemazón/el escozor, la sensación de cuerpo extraño, la sequedad de los ojos y el dolor, y se calculará la puntuación media («0» indica sin síntomas y «100» indica el peor síntoma jamás experimentado).
    3. Los pacientes deben dar su consentimiento informado por escrito.
    4. Los pacientes deben estar dispuestos y en condiciones de someterse y repetir las exploraciones programadas relacionadas con el estudio.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. History of the disease for less than 3 months (symptoms stabilized)
    2. Best corrected distance visual acuity (BCDVA) score ≥ +1.0 LogMAR (≤ 35 ETDRS letters, ≤ 20/200 Snellen or ≤ 0.1) in each eye
    3. Within the 3 months before the screening visit, history of ocular trauma, infection (viral, bacterial, fungal), inflammation not associated with dry eye

    Other exclusion criteria are defined in the protocol (they are referring to the ocular history, the medical history and the contraindications to treatment).
    No se podrá incluir en el estudio a aquellos pacientes que cumplan alguno de los siguientes criterios:
    1. antecedentes de la enfermedad durante menos de tres meses (síntomas estabilizados);
    2. puntuación de mejor agudeza visual a distancia corregida (MAVDC) ≥ +1,0 LogMAR (≤ 35 letras ETDRS, ≤ 20/200 Snellen o ≤ 0,1) en cada ojo;
    3. en los tres meses previos a la visita de selección, antecedentes de traumatismo ocular, infección (vírica, bacteriana o fúngica) o inflamación no asociada a la xeroftalmía.
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety variable is the incidence and severity of ocular and systemic adverse events throughout the study.

    The primary efficacy variable is CFS response in the worse eye at Month 6, defined as at least a 2-grade improvement from baseline, as assessed with the modified Oxford scale.
    La variable principal de seguridad es la incidencia y la gravedad de acontecimientos adversos oculares y sistémicos a lo largo del estudio.

    La variable principal de eficacia es la respuesta en la prueba de tinción CFS en el peor ojo al mes 6, definida como una mejora de al menos dos grados respecto al nivel inicial y que será evaluada mediante la escala de Oxford modificada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary safety variable
    Timepoint: Baseline and Months 1, 3, 6 and 9

    Primary efficacy variable
    Timepoint: at Month 6
    Variable principal de seguridad:
    Punto cronológico: inicio y en los meses 1, 3, 6 y 9.

    Variable principal de eficacia:
    Punto cronológico: al mes 6.
    E.5.2Secondary end point(s)
    Secondary safety and tolerability variables:
    • BCVA assessed in both eyes
    • Slit lamp examination performed in both eyes
    • IOP recorded for both eyes
    • Vital signs (blood pressure and heart rate)
    • Ciclosporin concentration in plasma

    Key secondary efficacy variable
    • Composite response endpoint (defined in the protocol and based on an improvement from baseline in CFS and VAS)

    Other secondary efficacy variables are defined in the protocol (eg. CFS assessment at different timepoints, VAS response, Shirmer test, TBUT...).
    Variables secundarias de seguridad y tolerabilidad:
    • AVMC evaluada en ambos ojos
    • Exploración con lámpara de hendidura en ambos ojos
    • TIO registrada de ambos ojos
    • Constantes vitales (tensión arterial y frecuencia cardiaca)
    • Concentración plasmática de ciclosporina

    Principal variable secundaria de eficacia:
    • Variable de respuesta compuesta (definida en el protocolo y basada en una mejora respecto al nivel inicial en la prueba CFS y la escala VAS).

    En el protocolo se definen otras variables secundarias de la eficacia, como la evaluación mediante CFS en distintos puntos cronológicos, la respuesta en la escala VAS, el resultado en la prueba de Shirmer o el tiempo de ruptura de la película lagrimal (TBUT).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary safety and tolerability variables:
    Timepoint: Baseline and Months 1, 3, 6 and 9 for all variables except ciclosporin concentration which will be assessed at baseline and Month 6.

    Key secondary efficacy variable
    Timepoint: Month 6
    Variables secundarias de seguridad y tolerabilidad:
    Punto cronológico: Inicio y meses 1, 3, 6 y 9 para todas las variables con la excepción de la concentración de ciclosporina, que se evaluará al inicio y en el mes 6.

    Principal variable secundaria de eficacia:
    Punto cronológico: mes 6.
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Hydromoor (lubricant drops)
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Denmark
    Netherlands
    Norway
    Portugal
    Spain
    Switzerland
    United Kingdom
    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
    last visit last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 77
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 143
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 234
    F.4.2.2In the whole clinical trial 264
    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. The sponsor may have the option to offer transfer to Moorfields Pharmaceuticals 0.06% Special.
    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 Decision2015-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-30
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