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    Summary
    EudraCT Number:2012-000044-10
    Sponsor's Protocol Code Number:QTM/OMN0114
    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:2012-02-06
    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 number2012-000044-10
    A.3Full title of the trial
    Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of the Fixed Combination Travoprost 40 µg/ml and Timolol 5 mg/ml Eye Drops vs. DuoTrav? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension
    Ensayo clínico fase III, aleatorizado, con dos grupos paralelos, enmascarado para el evaluador y abierto sobre la comparación de la eficacia y la tolerabilidad de una nueva formulación sin conservantes de la combinación fija de Travoprost 40 µg/mL y Timolol 5 mg/mL colirio frente a DuoTrav? colirio en pacientes con glaucoma primario de ángulo abierto o hipertensión ocular
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of the Fixed Combination Travoprost 40 µg/ml and Timolol 5 mg/ml Eye Drops vs. DuoTrav? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension
    Ensayo clínico fase III, aleatorizado, con dos grupos paralelos, enmascarado para el evaluador y abierto sobre la comparación de la eficacia y la tolerabilidad de una nueva formulación sin conservantes de la combinación fija de Travoprost 40 µg/mL y Timolol 5 mg/mL colirio frente a DuoTrav? colirio en pacientes con glaucoma primario de ángulo abierto o hipertensión ocular
    A.3.2Name or abbreviated title of the trial where available
    Non-inferiority of preservation-free travoprost fixed combination
    No inferioridad de la combinación fija de Travoprost y Timolol colirio sin conservantes
    A.4.1Sponsor's protocol code numberQTM/OMN0114
    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 SponsorOMNIVISION
    B.1.3.4CountryGermany
    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 supportOMNIVISION
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOMNIVISION
    B.5.2Functional name of contact pointMiriam Hoffmann
    B.5.3 Address:
    B.5.3.1Street AddressLindberghstr 7
    B.5.3.2Town/ cityPuchheim
    B.5.3.3Post codeD-82178
    B.5.3.4CountryGermany
    B.5.4Telephone number+4908984079253
    B.5.5Fax number+4908984079240
    B.5.6E-mailM.Hoffmann@omnivision-pharma.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 nameTravoprost+Timolol
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrapulmonary use (Noncurrent)
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL MALEATE
    D.3.9.1CAS number 26921-17-5
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRAVOPROST
    D.3.9.1CAS number 157283-68-6
    D.3.9.3Other descriptive nameTRAVOPROST
    D.3.9.4EV Substance CodeSUB12613MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 DuoTrav
    D.2.1.1.2Name of the Marketing Authorisation holderALCON LABORATORIES LTD.
    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 nameDuoTrav
    D.3.4Pharmaceutical form Eye drops
    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 INNTRAVOPROST
    D.3.9.1CAS number 157283-68-6
    D.3.9.3Other descriptive nameTRAVOPROST
    D.3.9.4EV Substance CodeSUB12613MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL MALEATE
    D.3.9.1CAS number 26921-17-5
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Open Angle Glaucoma or Ocular Hypertension
    Glaucoma de ángulo abierto o Hipertensión ocular
    E.1.1.1Medical condition in easily understood language
    Open Angle Glaucoma or Ocular Hypertension
    Glaucoma de ángulo abierto o Hipertensión ocular
    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 HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    The primary objective of this clinical trial is to demonstrate the non-inferiority of the investigational medicinal product containing the preservative-free combination of Travoprost (40 µg/ml), Timolol (5 µg/ml) in comparison with the commercially available preservative-containing comparator Travoprost/Timolol (DuoTrav?, Alcon Laboratories Ltd., UK) in the treatment of primary open angle glaucoma or ocular hypertension by the average decrease of diurnal IOP measured between baseline and last visit.
    El objetivo principal es demostrar la no inferioridad del producto en investigación que contiene la combinación fija de Travoprost (40 µg/ml) y Timolol (5 µg/ml) sin conservantes frente al comparador comercializado de Travoprost y Timolol (DuoTrav?, Alcon Laboratories Ltd. UK) con conservante, en el tratamiento del glaucoma primario de ángulo abierto o de la hipertensión ocular mediante la disminución media de la PIO diurna medida entre la visita basal y la última visita.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives are the average decreases of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial.
    Los objetivos secundarios de eficacia son los descensos medios de la PIO diurna medidos entre el momento basal y los días 7 y 14 y el porcentaje de paciente con una determinación de PIO <21 mm Hg al final del ensayo clínico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? male or female patients, of any race and ?18 years of age;
    ? diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension;
    ? on treatment with an IOP-lowering prostaglandin analogue/beta blocker combination for at least 6 months;
    ? on treatment with an IOP ?21 mmHg on medication measured as a mean of both eyes at two measurements at least one hour apart;
    ? best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes;
    ? in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures;
    ? expected by the investigator that IOP would remain controlled with the new treatment without optic nerve damage or progression of visual field loss;
    ? able to understand the requirements of the clinical trial and to agree to return for required follow-up visits;
    ? willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
    ? pacientes hombres o mujeres, de cualquier raza y ?18 años;
    ? que estén diagnosticados de glaucoma primario de ángulo abierto o hipertensión ocular;
    ? que estén en tratamiento con una combinación de un reductor de la PIO análogo de prostaglandina y un bloqueante beta durante al menos 6 meses;
    ? que estén en tratamiento con una PIO ?21 mmHg, determinada como la media de ambos ojos en dos mediciones realizadas al menos con una hora de diferencia;
    ? mejor agudeza visual corregida ?20 de 100 que corresponde a logMAR de 0,7 en ambos ojos
    ? en el caso de las mujeres, que sean posmenopáusicas (>12 meses sin periodo), estén esterilizadas quirúrgicamente o usen medidas anticonceptivas eficaces;
    ? en los que el investigador prevea que la PIO permanecerá controlada con el nuevo tratamiento sin dañar el nervio óptico y sin que avance la pérdida del campo visual;
    ? capaces de entender los requisitos del ensayo clínico y que estén dispuestos a acudir a las visitas de control necesarias;
    ? dispuestos a otorgar voluntariamente su consentimiento informado por escrito y a firmar la declaración de protección de datos antes de realizar cualquier procedimiento relacionado con el ensayo.
    E.4Principal exclusion criteria
    ? pre-treatment for primary open angle glaucoma or intraocular hypertension other than prostaglandin analogue/beta blocker combinations;
    ? a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
    ? narrow-angle/angle-closure glaucoma;
    ? clinically significant or progressive retinal disease;
    ? intraocular surgery within the past 6 months;
    ? ocular laser surgery within the past 3 months;
    ? a change in glaucoma therapy within 1 month before the screening visit;
    ? best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8;
    ? history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
    ? treatment with local or systemic corticosteroids;
    ? inability to discontinue the use of glucocorticoid medications;
    ? not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine);
    ? a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial or a contraindication of ß-adrenergic receptor antagonists due to systemic disease;
    ? sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock
    ? pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
    ? current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
    ? unwillingness or inability to comply with the clinical trial procedures;
    ? unwillingness to consent to storage and saving and transmission of pseudonymous medical data for clinical trial reasons;
    ? who are legally incapacitated,
    ? who are legally detained in an official institute.
    ? tratamiento previo para el glaucoma primario de ángulo abierto o hipertensión intraocular que no sea con un análogo de prostaglandina y un bloqueante beta
    ? antecedentes de enfermedad inflamatoria ocular crónica o recurrente, traumatismos o infecciones oculares;
    ? glaucoma de ángulo estrecho o ángulo cerrado;
    ? retinopatía clínicamente importante o progresiva;
    ? cirugía intraocular en los 6 últimos meses;
    ? cirugía ocular con láser en los 3 últimos meses;
    ? cambio en el tratamiento del glaucoma en el mes anterior a la visita de selección;
    ? mejor agudeza visual corregida inferior a 0,7 logaritmo del ángulo mínimo de resolución (logMAR), ángulo muy estrecho o parcialmente cerrado, relación copa/disco >0,8;
    ? antecedentes de asma bronquial o enfermedad pulmonar obstructiva crónica grave; enfermedad reactiva de las vías respiratorias.
    ? tratamiento con corticosteroides locales o sistémicos;
    ? incapacidad para suspender el uso de glucocorticoides;
    ? dosis inestables de algún medicamento que pudiera afectar a la PIO en los 30 días anteriores al inicio del ensayo clínico (p. ej., clonidina);
    ? antecedentes de hipersensibilidad alérgica o mala tolerancia a cualquier componente de la solución en colirio usada en este ensayo clínico o contraindicación de los antagonistas de los receptores adrenérgicos ß por enfermedad sistémica;
    ? bradicardia sinusal, bloqueo auriculoventricular de segundo o tercer grado, insuficiencia cardiaca franca o choque cardiogénico;
    ? embarazo o lactancia o edad fértil sin protección mediante un método anticonceptivo eficaz;
    ? participación actual o que no haya terminado todavía el periodo de al menos 30 días desde la finalización de la participación en otro(s) ensayo(s) clínico(s) de un fármaco o dispositivo en investigación
    ? poca disposición o incapacidad para completar los procedimientos del ensayo clínico;
    ? poca disposición a otorgar el consentimiento para la conservación, grabación y transmisión de los datos médicos bajo pseudónimo por razones del ensayo clínico;
    ? incapacidad legal,
    ? detenidos legalmente en una institución oficial.
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate the non-inferiority of the investigational medicinal product containing the preservative-free combination of Travoprost (40 µg/ml), Timolol (5 µg/ml) in comparison with the commercially available preservative-containing comparator Travoprost/Timolol (DuoTrav?, Alcon Laboratories Ltd., UK) in the treatment of primary open angle glaucoma or ocular hypertension by the average decrease of diurnal IOP measured between baseline and last visit.
    Demostrar la no inferioridad del producto en investigación que contiene la combinación fija de Travoprost (40 µg/ml) y Timolol (5 µg/ml) sin conservantes frente al comparador comercializado de Travoprost y Timolol (DuoTrav?, Alcon Laboratories Ltd. UK) con conservante, en el tratamiento del glaucoma primario de ángulo abierto o de la hipertensión ocular mediante la disminución media de la PIO diurna medida entre la visita basal y la última visita.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary end point(s)
    The average decreases of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial.
    Descensos medios de la PIO diurna medidos entre el momento basal y los días 7 y 14 y el porcentaje de paciente con una determinación de PIO <21 mm Hg al final del ensayo clínico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    enmascarado para el evaluador
    Observer-blind
    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 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 concerned4
    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 patient
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state166
    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)
    No
    No
    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 Decision2015-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-03-13
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