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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-002183-63
    Sponsor's Protocol Code Number:IOBA-CERLab-003-2013
    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:2013-06-10
    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 number2013-002183-63
    A.3Full title of the trial
    Unicenter, double masked, crossover clinical trial to assess the efficacy of FML (0.1% Fluorometolone) in dry eye patients
    Ensayo clínico, unicéntrico, doble enmascarado, cruzado, para evaluar la eficacia de FML® Suspensión oftálmica (Fluorometolona 0,1%, Allergan INC) en pacientes con síndrome de ojo seco
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of FML in dry eye patients
    Eficacia de FML en pacientes con ojo seco
    A.4.1Sponsor's protocol code numberIOBA-CERLab-003-2013
    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 SponsorIOBA
    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 supportIOBA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIOBA
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Belen 17
    B.5.3.2Town/ cityValladolid
    B.5.3.3Post code47011
    B.5.3.4CountrySpain
    B.5.4Telephone number34983184734
    B.5.5Fax number34983186375
    B.5.6E-mailblazquez@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 FML
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN
    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, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 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.2.1.1.1Trade name Liquifilm Artificial Teardrop
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan
    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 IMPTopical use (Noncurrent)
    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 syndrome (DES)
    Síndrome de ojo seco (SOS)
    E.1.1.1Medical condition in easily understood language
    Dry Eye Syndrome
    Síndrome de 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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10013777
    E.1.2Term Dry eye syndrome
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10013774
    E.1.2Term Dry eye
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the efficacy under adverse controlled environmental conditions of FML in dry eye syndrome
    Evaluar la eficacia, bajo condiciones ambientales adversas, de un antiinflamatorio utilizado habitualmente en el tratamiento de signos y síntomas de SOS.
    E.2.2Secondary objectives of the trial
    Assess and compare ocular surface staining (corneal and conjunctival) with the study product and the comparator
    Assess and compare dry eye symptoms with OSDI and SANDE with the study product and the comparator
    Assess and compare user satisfaction with an 0-100 analog scale with the study product and the comparator
    Assess and compare tear film by Tear Breakup Time Test (TBT) with the study product and the comparator
    Assess and compare visual function with ETDRS visual acuity test with the study product and the comparator
    Assess and compare changes in intraocular pressure and eye fundus with the study product and the comparator
    Assess ocular, orbitary and systemic adverse events
    Assess every serious adverse event during the study
    Valorar y comparar la presencia de tinción en la superficie ocular (córnea y conjuntiva) utilizando el producto en estudio y el producto control.
    Valorar y comparar la sintomatología de sequedad ocular con los cuestionarios OSDI y SANDE utilizando el producto en estudio y el producto control.
    Valorar y comparar la satisfacción del usuario, mediante una escala de valoración visual de 0 a 100, utilizando el producto en estudio y el producto control.
    Valorar y comparar la estabilidad de la película lagrimal mediante la medida del BUT utilizando el producto en estudio y el producto control.
    Valorar y comparar la función visual mediante el test ETDRS utilizando el producto en estudio y el producto control.
    Valorar y comparar los cambios en presión intraocular y fondo de ojo utilizando el producto en estudio y el producto control
    Valorar los acontecimientos adversos oculares, periorbitarios y sistémicos.
    Valorar los acontecimientos adversos graves
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient ≥ 18 years old
    Worsening of pathology when exposed to adverse environmental conditions during normal life
    Corneal staining ≥ 1 in both eyes using Oxford Scale
    OSDI symptoms > 12 points
    TBT ≤ 7 seconds in both eyes
    Schirmer Test without anesthesia ≤ 10 mm after 5 minutes in both eyes.
    Any medication that may affect DES, ocular surface or vision must have started at least 3 months before inclusion and no dose changes are expected during study
    BCVA at least 0.1 logMar at 6 meters with both eyes
    Use of artificial teardrops at inclusion
    Signed informed consent prior to any study procedure
    Signed Data protection form prior to any study procedure
    Hombre o mujer de edad igual o superior a 18 años, capaz de otorgar libremente el consentimiento informado para la participación en el estudio.
    Los sujetos deben referir empeoramiento de su estado cuándo se ven expuesto a condiciones ambientales adversas durante su vida diaria.
    Tinción corneal con fluoresceína ≥ 1 en ambos ojos en la escala Oxford
    Sintomatología con el test de OSDI mayor de 12 puntos.
    BUT ≤ 7 segundos en ambos ojos.
    Test de Schirmer sin anestesia ≤ 10 mm en 5 minutos en ambos ojos.
    Cualquier medicación que pueda afectar al SOS, estado de la superficie ocular o visión, debe haber comenzado a administrarse al menos 3 meses antes del momento de la visita de inclusión y no debe ser esperable que se produzcan cambios en la dosis de los tratamientos durante el desarrollo del estudio.
    Agudeza visual corregida de al menos 0.1 logMar a 6 metros con cada ojo.
    Estar utilizando en el momento de la inclusión lágrimas artificiales.
    Firma del consentimiento informado (Anexo II) previa a cualquier prueba del estudio.
    Firma del formulario de protección de datos previo a cualquier prueba del estudio.
    E.4Principal exclusion criteria
    Known sensitivity or intolerance to any of the products used in the study
    Story of ocular infection or inflammation during the 6 previous months to study inclusion
    Any active ocular pathology (except dry eye syndrome)
    Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution (cataract or refractive surgery) within the 6 previous months to study inclusion or any ocular o systemic surgery planned to happen during the study thay in the investigator´s opinion may jeopardize the study
    Use of contact lenses within 3 months prior to study inclusion
    Use of any topical medication except those used for DES
    Ocular treatment for DES with corticosteroids or non-steroid antiinflamatories within 1 month prior to study inclusion or 3 months before inclusion in case of treatment with Cyclosporin
    Any uncontrolled systemic disease that may affect the eye (except primary or secondary Sjögren Syndrome)
    Start, discontinuation or dose change within the study of antihistaminics, cholinergic agents, beta-blockers, antidepressants or any other medication with potential effect over tear film
    Start of any systemic treatment that may affect DES, vision, ocular surface or intraocular pressure, during the 3 previous months to study inclusion
    Occlusion of lacrimal points, surgical or non surgical, in the 3 previous months of study inclusion or expected necessity of occlusion during the study
    Cup / Disc ration > 0.6
    Story of glaucoma or intraocular pressure > 22mm Hg in any measurement done within the 2 previous months to study inclusion
    Pregnancy or breastfeeding women
    Participation in any clinical trial within the last 30 days before study inclusion
    Sensibilidad o intolerancia conocidas a algunos de los productos utilizados en el estudio.
    Historia de infecciones oculares o inflamación severa en los 6 meses previos al estudio.
    Cualquier patología ocular activa (excepto SOS).
    Cualquier cirugía ocular o traumatismo que pueda afectar a la sensibilidad corneal y/o a la distribución lagrimal normal (cirugía de cataratas, cirugía refractiva) en los 6 meses previos al estudio o cualquier cirugía ocular o sistémica planificada durante la realización del estudio que en opinión del investigador pueda afectar al desarrollo del mismo.
    Uso de lentes de contacto durante los 3 meses previos al estudio.
    Uso de cualquier medicación tópica que no sea para el tratamiento del SOS.
    Tratamiento ocular tópico para el tratamiento del SOS con corticoides o antiinflamatorios no esteroideos 1 mes antes de la visita de inclusión o con Ciclosporina A 3 meses antes de la misma.
    Cualquier enfermedad sistémica grave descontrolada que pueda afectar al ojo (excepto síndrome de Sjögren primario o secundario).
    Inicio, discontinuación o cambio a lo largo del estudio en la dosis de antihistamínicos, agentes colinérgicos, agentes beta-bloqueantes, antidepresivos o cualquier otra medicación sistémica con posibles efectos sobre la película lagrimal.
    Inicio de cualquier tratamiento sistémico que pueda afectar al SOS, la visión, el estado de la superficie ocular o la presión intraocular del paciente, durante los 3 meses previos a la visita de inclusión.
    Oclusión de los puntos lagrimales, tanto quirúrgica como no quirúrgica, en los tres meses previos a la visita de inclusión, o previsión de realizar dicha oclusión durante la realización del estudio.
    Relación excavación/papila > 0.6
    Historia de glaucoma o presión intraocular > 22 mmHg en cualquier medida realizada durante los 2 meses previos a la visita de inclusión.
    Embarazo o lactancia.
    La participación del sujeto en un ensayo clínico durante los últimos 30 días.
    E.5 End points
    E.5.1Primary end point(s)
    A) Fluorescein corneal staining

    I.- Proportion of subjects with corneal staining reduction ≥ 1 point after normalization environmental conditions after 7 days of treatment with test drug vs same conditions with control product.
    II.- Proportion of subjects with corneal staining increase ≥ 1 point after exposure to adverse conditions after 7 days of use of study treatment with test drug vs same conditions with control product

    B) SANDE I and II questionnaries. Proportion of subjects with reduction of ≥ 2 puntos in SANDE after 7 days of treatment with test drug vs same conditions with control product.
    A) Tinción corneal con fluoresceína:
    I.- Proporción de sujetos con una reducción de la tinción corneal con fluoresceína ≥ 1 punto tras exposición a las condiciones ambientales de normalización tras 7 días de uso del tratamiento en
    ´┐╝´┐╝´┐╝Estudio Clínico IOBA-CERLab 003-2013 (V1.0) Página 23 de 55
    estudio, con respecto a la proporción de sujetos con la misma cantidad de reducción de tinción corneal con fluoresceína, y en las mismas condiciones ambientales, tras 7 días de tratamiento con el producto control.
    II.- Proporción de sujetos con un incremento de la tinción corneal con fluoresceína ≥ 1 punto tras exposición a las condiciones ambientales adversas tras 7 días de uso del tratamiento en estudio, con respecto a la proporción de sujetos con la misma cantidad de aumento de tinción corneal con fluoresceína tras exposición a las condiciones ambientales adversas tras 7 días de tratamiento con el producto control.
    B) Cuestionario SANDE I y II tras tratamiento: Proporción de sujetos con una reducción ≥ 2 puntos en la puntuación de los cuestionarios SANDE tras 7 días de uso del tratamiento de estudio respecto a la proporción de sujetos con reducción en la puntuación de dichos cuestionarios tras 7 días de utilización del tratamiento control.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1a) 7 days of treatment after normalization conditions
    1b) 7 days of treatment after adverse conditions

    2) After 7 days of treatment
    1a) 7 dias de tratamiento tras condiciones de normalización
    1b) 7 días de tratamiento tras condiciones adversas

    2) Tras 7 días de tratamiento
    E.5.2Secondary end point(s)
    A) Tear protein levels:
    I.- Evidence of statistically significant changes in any of the studied molecules before and after treatment after exposure to normal conditions for both treatments.
    II.- Evidence of statistically significant changes in any of the studied molecules before and after treatment after exposure to adverse conditions and after recovery visit for both treatments.
    A) Niveles de proteínas lagrimales:
    I.- Evidencia de cambios estadísticamente significativos en cualquiera de las moléculas estudiadas entre los niveles existentes antes y después de la utilización de cada uno de los tratamientos, tras exposición del paciente a condiciones de normalización.
    II.- Evidencia de cambios estadísticamente significativos en cualquiera de las moléculas estudiadas entre los niveles existentes antes y después de la exposición a condiciones ambientales adversas y en la visita de recuperación tras utilización de cada uno de los tratamientos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) After exposure to normal conditions
    2) after exposure to adverse conditions and after recovery visit
    1) Tras exposición a condiciones normales
    2) Tras exposición a condiciones adversas y tras la visita de recuperación
    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 No
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    Liquifilm® lágrimas artificiales esteriles (Allergan INC.)
    Liquifilm® artificial sterile teardrops (Allergan INC.)
    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
    Último paciente, Última visita
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state24
    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 Decision2013-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-31
    P. End of Trial
    P.End of Trial StatusOngoing
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