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    Summary
    EudraCT Number:2016-000176-20
    Sponsor's Protocol Code Number:GLJ576-P001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-20
    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 number2016-000176-20
    A.3Full title of the trial
    Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV)
    Seguridad y eficacia de brinzolamida al 1 %/brimonidina al 0,2 % (SIMBRINZA) dos veces al día como terapia adyuvante a travoprost al 0,004 %/ timolol al 0,5 % (DUOTRAV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the combined effect of Simbrinza with another eye medication on Glaucoma
    Un estudio para investigar el efecto combinado de Simbrinza con otro medicamento oftálmico para el glaucoma
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of Simbrinza as an Adjunctive to DuoTrav
    Seguridad y eficacia de SIMBRINZA como adyuvante a DUOTRAV
    A.4.1Sponsor's protocol code numberGLJ576-P001
    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 SponsorAlcon Research Ltd
    B.1.3.4CountryUnited States
    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 supportAlcon Research Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlcon Eye Care (UK) Ltd
    B.5.2Functional name of contact pointEMEA Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressRiverside Way, Watchmoor Park
    B.5.3.2Town/ cityCamberley
    B.5.3.3Post codeGU15 3YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailemea.ra@alcon.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 Yes
    D.2.1.1.1Trade name Simbrinza
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 IMPOcular use
    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, suspension
    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 Hypertension
    Open-angle Glaucoma
    Hipertensión ocular
    Glaucoma de ángulo abierto
    E.1.1.1Medical condition in easily understood language
    Increased pressure in the eye
    Glaucoma
    Aumento de la presión en el ojo
    Glaucoma
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10030348
    E.1.2Term Open angle glaucoma
    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 demonstrate the additive IOP lowering effect of Brinzolamide 1%/Brimonidine 0.2% (dosed BID) when added to Travoprost 0.004%/Timolol 0.5% solution in subjects with open-angle glaucoma or ocular hypertension
    Demostrar el efecto aditivo reductor de la PIO con brinzolamida al 1 %/brimonidina al 0,2 % (administrado dos veces al día) al adicionarlo a la solución de travoprost al 0,004 %/timolol al 0,5 % en sujetos con glaucoma de ángulo abierto o hipertensión ocular.
    E.2.2Secondary objectives of the trial
    Not applicable
    No procede.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension
    - Currently on treatment with Travoprost 0.004%fTimolol 0.5% prescribed as approved in the country, on evening dosing for at least 28 days prior to screening, and In the opinion of the Investigator may benefit from further lOP lowering
    - Mean lOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ? 21 and ? 28 mmHg at 9:00 while on a Travoprost 0.004%/ Timolol 0.5% solution)
    - Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee
    - Willing and able to attend all study visits
    - Other protocol-defined inclusion criteria may apply
    - Pacientes diagnosticados de glaucoma de ángulo abierto (incluido el glaucoma de pseudoexfoliación o por dispersión pigmentaria) o hipertensión ocular.
    - Pacientes tratados en la actualidad con Travoprost 0,004 %/Timolol 0,5 % prescripto según aprobado en el país, administrado por la noche durante al menos 28 días antes de la selección, y que a criterio del Investigador pueden beneficiarse de un descenso adicional de la PIO.
    - Mediciones medias de PIO aptas tanto en la Visita de elegibilidad 1 como en la Visita de elegibilidad 2, en al menos 1 ojo (el mismo o los mismos ojos) ?21 y ?28 mmHg a las 09:00 h, estando con solución de Travoprost al 0,004 % /Timolol al 0,5 %.
    - Debe ser capaz de comprender y firmar el formulario de consentimiento informado que haya sido aprobado por una Junta de Revisión Institucional/ Comité de Ético
    - Debe estar dispuesto y poder acudir a todas las visitas del estudio
    - Pueden aplicarse otros criterios de inclusión definidos en el protocolo
    E.4Principal exclusion criteria
    - Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
    - Any form of glaucoma other than open-angle glaucoma or ocular hypertension
    - Severe central visual field loss in either eye
    - Chronic, recurrent or severe Inflammatory eye disease In either eye
    - Ocular trauma in either eye within the past 6 months prior to the Screening visit
    - Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit
    - Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye
    - Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye
    - Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication
    - Intraocular surgery in either eye within the past 6 months prior to the Screening visit
    - Ocular laser surgery in either eye within the past 3 months prior to the Screening visit
    - Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study
    - Asthma, history of asthma, or severe chronic obstructive pulmonary disease
    - Other protocol-defined exclusion criteria may apply
    - Las mujeres con capacidad reproductiva (women of childbearing potential, WOCBP), definidas como todas las mujeres que no son postmenopáusicas hace al menos 1 año, o que hubieran transcurrido menos de 6 semanas de una esterilización, están excluidas de la participación si están embarazadas en este momento, o bien dan resultado positivo en la prueba de embarazo de orina en la Selección, o bien tienen la intención de quedar embarazadas durante el período del estudio, o bien están en período de lactancia, o bien no están de acuerdo en usar métodos anticonceptivos adecuados para evitar el embarazo durante el transcurso del estudio.
    - Sujetos que presenten cualquier otra forma de glaucoma distinto del glaucoma de ángulo abierto o hipertensión ocular.
    - Sujetos con pérdida severa de campo visual central en cualquiera de los ojos.
    - Sujetos con enfermedad ocular inflamatoria crónica, recurrente o severa en cualquiera de los ojos.
    - Sujetos con traumatismo ocular en cualquiera de los ojos en los 6 meses anteriores a la Visita de selección.
    - Sujetos con infección o inflamación ocular en cualquiera de los ojos en los 3 meses anteriores a la Visita de selección.
    - Sujetos con retinopatía progresiva o clínicamente significativa, como degeneración retiniana, retinopatía diabética o desprendimiento de retina en cualquiera de los ojos.
    - Sujetos con un puntaje de mejor agudeza visual corregida inferior a 55 letras ETDRS (equivalente a aproximadamente 20/80 Snellen, 0,60 logMAR o 0,25 decimal) en cualquiera de los ojos.
    - Sujetos con otra patología ocular (incluido el ojo seco severo) en cualquiera de los ojos, que pudiera, a criterio del Investigador, impedir la administración segura de cualquiera de las medicaciones del estudio.
    - Sujetos sometidos a cirugía intraocular en cualquiera de los ojos en los 6 meses anteriores a la Visita de selección.
    - Sujetos sometidos a cirugía ocular láser en cualquiera de los ojos en los 3 meses anteriores a la Visita de selección.
    - Cualquier otra afección, incluidas las enfermedades graves que, a criterio del investigador, hiciese que el sujeto no resultase apto para el estudio.
    - Participantes del estudio con asma, antecedentes de asma o enfermedad pulmonar obstructiva crónica severa.
    - Pueden aplicarse otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in Diurnal lOP at Week 6
    Cambio en la PIO diurna con respecto al valor basal en la Semana 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    Semana 6
    E.5.2Secondary end point(s)
    - Diurnal lOP at Week 6
    - Percentage Change from Baseline in Diurnal lOP at Week 6
    - Change from Baseline in lOP for Each Time Point (09:00, 11 :00, 15:00) at Week 6
    - Percentage Change from Baseline in lOP for Each Time Point (09:00, 11 :00, 15:00) at Week 6
    - PIO diurna en la Semana 6
    - Cambio porcentual en la PIO diurna con respecto al valor basal en la Semana 6
    - Cambio en la PIO con respecto al valor basal para cada instancia temporal (09:00 h, 11:00 h, 15:00 h) en la Semana 6
    - Cambio porcentual en la PIO desde el valor basal hasta la Semana 6 para cada instancia temporal (09:00 h, 11:00 h, 15:00 h)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 6
    Semana 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 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 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA17
    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
    Argentina
    Australia
    Chile
    Colombia
    Korea, Republic of
    Taiwan
    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
    última visita último paciente
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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)
    Not different from the expected normal treatment for the condition
    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 Decision2016-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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