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    Summary
    EudraCT Number:2014-005379-10
    Sponsor's Protocol Code Number:HUS_MON_2014-01
    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:2015-03-03
    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 number2014-005379-10
    A.3Full title of the trial
    Study of tear osmolarity and Quality of Life on patients treated with unpreserved latanoprost 0.005%
    ESTUDIO DE LA OSMOLARIDAD DE LA LÁGRIMA Y DE LA CALIDAD DE VIDA EN PACIENTES TRATADOS CON LATANOPROST 0.005% SIN CONSERVANTES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tear concentration study and quality of life on patients treated with unpreserved latanoprost 0.005%
    Estudio de la concentración de la lágrima y de la calidad de vida en pacientes tratados con latanoprost 0.005% sin conservantes
    A.4.1Sponsor's protocol code numberHUS_MON_2014-01
    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 SponsorEmiliano Hernández Galilea
    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 supportLanboratorios Thea
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEmiliano Hernández Galilea
    B.5.2Functional name of contact pointLourdes De Juan
    B.5.3 Address:
    B.5.3.1Street AddressPaseo San Vicente 88-182
    B.5.3.2Town/ citySalamanca
    B.5.3.3Post code37007
    B.5.3.4CountrySpain
    B.5.4Telephone number34923291100427
    B.5.5Fax number34934766811
    B.5.6E-maillourdes.juan@usal.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 Monoprost
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Théa
    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.3.1Product nameMonoprost
    D.3.4Pharmaceutical form Eye drops, suspension in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlatanoprost
    D.3.9.1CAS number 130209-82-4
    D.3.9.3Other descriptive nameLATANOPROST
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50
    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 Xalatan
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer S.L.
    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.3.1Product nameXalatan
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlatanoprost
    D.3.9.1CAS number 130209-82-4
    D.3.9.3Other descriptive nameLATANOPROST
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50
    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
    Chronic open angle glaucoma and ocular hypertension
    Glaucoma crónico de ángulo abierto e hipertensión ocular
    E.1.1.1Medical condition in easily understood language
    Patients showing pathological intraocular pressure increase with or without optic nerve damage.
    Pacientes con una elevación de la presión intraocular considerada como patológica incluyendo lesión del nervio óptico o no.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    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
    To evaluate and compare tear osmolarity after the use of preserved latanoprost and non-preserved latanoprost in the study subjects.
    Evaluar y comparar la osmolaridad de la lágrima después del uso de latanoprost con conservantes y de latanoprost sin conservantes en los sujetos del estudio
    E.2.2Secondary objectives of the trial
    - To evaluate and compare the effect of both treatments on intraocular pressure.
    - To evaluate the correlation between tear osmolarity and the results of the Ocular Surface Disease Index (OSDI) questionnaire.
    - To evaluate the correlation between tear osmolarity and the clinical tests of dry eye.
    - Evaluar y comparar el efecto de ambos tratamientos sobre la presión intraocular
    - Evaluar la correlación existente entre la osmolaridad de la lágrima y los resultados del cuestionario ?Ocular Surface Disease Index? (OSDI)
    - Evaluar la correlación existente entre la osmolaridad de la lágrima y las pruebas clínicas de ojo seco
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 years or older with ocular hypertension or chronic open-angle glaucoma treated with preserved latanoprost 0.005% during at least 6 months.
    - Patients capable of signing informed consent and of complying with the protocol.
    - Pacientes mayores de edad con hipertensión ocular o glaucoma crónico de ángulo abierto tratados con latanoprost 0.005% con conservantes durante al menos 6 meses
    - Pacientes capaces de firmar un consentimiento informado y de cumplir con el protocolo.
    E.4Principal exclusion criteria
    Ocular exclusion criteria
    - Patients diagnosed with other eye diseases capable of altering the ocular surface (altered blinking function or eyelid anatomy, corneal dystrophy of any kind, ectasias, etc.).
    - Any eye disease or surgery requiring topical treatment during the 6 months before the study.
    - Patients with established glaucoma or ocular hypertension failing to respond to prostaglandins or which cannot be controlled with a single antiglaucoma drug.
    - Patients with severe visual field loss.
    - Patients who are using or have used antiglaucoma eyedrops different from the study products or preserved artificial tears in the previous 6 months.
    - Patients with a history of ocular trauma, infection or inflammation.
    - Patients wearing contact lenses on the inclusion visit and throughout the study.
    - Patients who have undergone any kind of eye surgery (including laser refractive surgery, intraocular surgery and eyelid surgery) capable of modifying the patient?s corneal surface.
    - Patients who will require surgery in the course of the study.
    - Patients with herpetic keratitis or a history of herpetic keratitis.
    - Patients diagnosed with any other cause of glaucoma (congenital, pigmentary, inflammatory, closed-angle, etc.).
    - Patients with aphakia, pseudoaphakia with tearing of the posterior lens capsule, or anterior chamber intraocular lenses.
    - Patients with a history of (or risk factors for) cystoid macular edema.
    - Patients susceptible to iritis and/or uveitis.

    Non-ocular exclusion criteria
    - Patients with non-stabilized systemic disease during at least 6 months prior to the screening visit (uncontrolled arterial hypertension, thyroid gland dysfunction, uncontrolled autoimmune disorders, patients with inadequate metabolic control ? including blood glucose outside ranges), or which precludes correct performance of the tests.
    - Patients receiving systemic treatment with drugs exerting antihypertensive effects (beta-blockers, corticosteroids, acetazolamide, etc.), or who have used such drugs in the 2 months before inclusion in the study.
    - Patients with known hypersensitivity to any of the ingredients of the study product or to drug substances belonging to the same family as any of the ingredients of the study product or which are used in the exploratory examinations / procedures.
    - Women who are pregnant or breastfeeding at the time of the inclusion visit.
    - Patients with mental alterations preventing compliance with the requirements of the study.
    - Patients who do not agree to report to the protocolized visits or who refuse to follow the instructions related to the study procedures as explained by the investigator.

    Compliance / administrative exclusion criteria:
    - Suspected or confirmed illegal drug abuse.
    - Participation in this same study in the past or in another clinical study in the 30 days before the screening visit.
    - Incapacity of the patient and/or relatives to understand the study procedures, and thus inability to give informed consent.
    - Non-compliers, i.e., patients who fail to report to the follow-up visits or whose life style interferes with the protocol compliance.
    - Patients under legal custody.
    Criterios de exclusión oculares
    - Pacientes con diagnóstico de otra patología ocular que pueda alterar la superficie ocular (anatomía palpebral o función de parpadeo alterada, cualquier tipo de distrofia corneal, ectasias...)
    - Cualquier cirugía o enfermedad ocular que requiera tratamiento tópico durante 6 meses previo al estudio
    - Pacientes con glaucoma establecido o hipertensión ocular que no respondan a prostaglandinas o que no pueda controlarse con un solo fármaco antiglaucomatoso.
    - Pacientes con pérdida de campo visual severa.
    - Pacientes que utilicen o hayan utilizado un colirio antiglaucomatoso diferente a los productos a estudio o lágrimas artificiales con conservantes los 6 meses anteriores.
    - Historia de traumatismo ocular, infección o inflamación ocular.
    - Pacientes portadores de lentes de contacto en la visita de inclusión y durante la totalidad del estudio.
    - Pacientes que hayan sido sometidos a cualquier cirugía ocular (incluyendo cirugía refractiva con láser, cirugías intraoculares y cirugías palpebrales) que pueda modificar la superficie corneal de los pacientes.
    - Pacientes que vayan a requerir cirugía a lo largo del estudio.
    - Pacientes con queratitis herpética en curso o con antecedentes de la misma
    - Paciente con diagnóstico de cualquier otra causa de glaucoma (congénito, pigmentario, inflamatorio, de ángulo cerrado, ..)
    - Pacientes afáquicos, pseudofáquicos con desgarro de la cápsula posterior del cristalino o lentes intraoculares de la cámara anterior
    - -Pacientes con antecedentes o que presentes factores de riesgo para desarrollar edema macular cistoide
    - Pacientes con predisposición a iritis y/o uveitis

    Criterios de exclusión no oculares
    - Pacientes con una enfermedad sistémica no estabilizada en un periodo de al menos 6 meses antes de la visita de selección (hipertensión arterial descontrolada, mal funcionamiento de tiroides, enfermedad autoinmune no controlada, pacientes con control metabólico inadecuado incluyendo una glicemia fuera de rango...) o que impida la realización correcta de las pruebas.
    - Pacientes bajo tratamiento sistémico con fármacos con capacidad antihipertensiva (beta-bloqueantes, corticoides, acetazolamida...) o que los hayan usado los 2 meses previos a la inclusión en el estudio.
    - Pacientes con hipersensibilidad conocida a alguno de los componentes del producto del estudio, a principios activos de la misma familia que alguno de los componentes del producto a estudio o que se utilizan en los procedimientos/exámenes exploratorios.
    - Mujeres en situación de embarazo o lactancia en la visita de inclusión.
    - Pacientes con un estado mental alterado o que le incapacite para cumplir con las exigencias del estudio.
    - Pacientes que no acepten asistir a las visitas propuestas por el protocolo o que no acepten seguir las instrucciones relacionadas con los procedimientos del estudio que les explicará el investigador.

    Criterios de exclusión de cumplimiento/administrativo:
    - Sospecha o confirmación de consumo de drogas ilegales.
    - Participación en este mismo estudio con anterioridad o en otro estudio clínico en los 30 días previos a la visita de selección.
    - Incapacidad del paciente y/o familiares de comprender los procedimientos del estudio y por lo tanto incapacidad para dar el consentimiento informado.
    - Pacientes no cumplidores, es decir, que no acudan a las visitas de seguimiento o que su forma de vida interfiera con el cumplimiento del protocolo.
    - Paciente bajo tutela judicial
    E.5 End points
    E.5.1Primary end point(s)
    -Evaluation of the osmolarity value of the tear film
    -Evaluación del valor de osmolaridad de la película lagrimal
    E.5.1.1Timepoint(s) of evaluation of this end point
    To be done on D-15, D28 and D84.
    Realizada en D-15, D28, y D84
    E.5.2Secondary end point(s)
    -Evaluation of the quality of life index measured from the Ocular Surface Disease Index (OSDI)
    - Evaluation of the intraocular pressure values
    - Evaluation of the Schirmer test without anesthesia .
    - Evaluation of the tear breakup time (TBUT) values
    - Evaluation of the results of corneal staining (Oxford scheme) .
    - Evaluation of the treatment safety, determining and classifying simple and serious AE, related or not to the study treatment, which appear in the fellow eye. The percentage of these events will be the cumulative value on the visits , in both treatment groups.
    -Evaluación del índice de calidad de vida medido a través del cuestionario ?Ocular Surface Disease Index? (OSDI).
    - Evaluación de los valores de PIO.
    - Evaluación de los valores de test de Schirmer sin anestesia.
    - Evaluación de los valores de tiempo de ruptura de la película lagrimal (TBUT).
    - Evaluación de los valores de tinción corneal (esquema de Oxford).
    - Evaluación de la seguridad del tratamiento determinando y tipificando los AA simples y graves, relacionados o no con el tratamiento a estudio que aparezcan en el ojo contralateral. El porcentaje de estos acontecimientos será el acumulado en las visitas en ambos grupos de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    -To be done on D-15, D28 and D84.
    -To be done on D-15, D28 and D84.
    -To be done on D-15, D28 and D84.
    -To be done on D-15, D28 and D84.
    -To be done on D-15, D28 and D84
    -To be done on D28 and D84
    -En D-15, D28 y D84.
    -En D-15, D28 y D84.
    -En D-15, D28 y D84.
    -En D-15, D28 y D84.
    -En D-15, D28 y D84.
    -En D28 y D84
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    Last visit last subject
    Última visita último paciente
    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 months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 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
    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 Decision2015-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
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