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    Summary
    EudraCT Number:2007-000515-29
    Sponsor's Protocol Code Number:EMD-06-03
    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:2007-07-04
    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 number2007-000515-29
    A.3Full title of the trial
    Adherencia de los pacientes en el uso de Travalert® para la instilación de una combinación fija de travoprost 0.004% / timolol 0.5% comparado con un régimen concomitante de travoprost 0.004% y timolol 0.5%
    (Patients adherence using Travalert® to a fixed combination of travoprost 0.004% / timolol 0.5% compared to a concomitant regimen of travoprost 0.004% plus timolol 0.5%)

    A.4.1Sponsor's protocol code numberEMD-06-03
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlcon Laboratories Inc.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DUOTRAV
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK) 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, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name TRAVATAN
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK) 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 nameTRAVATAN
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Timolol Falcon
    D.2.1.1.2Name of the Marketing Authorisation holderS.A. Alcon Couvreur N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameTIMOLOL FALCON
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Reducción de la presión intraocular en pacientes con glaucoma de angulo abierto o con hipertensión ocular, que no respondan a monoterapia de betabloqueantes o análogos de las prostaglandinas

    Intraocular pressure reduction in patients with open-angle glaucoma, or intraocular hypertension when they do not respond to betablockers or ophthalmic prostaglandin analog monotherapy.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10030348
    E.1.2Term Open angle glaucoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es comparar la adherencia de los pacientes en combinación fija de travoprost 0.004% / timolol 0.5% y pacientes en combinación concomitante de travoprost 0.004% y timolol 0.5%, utilizando el aparato Travalert®.

    (The primary target is to compare the patients adherence using Travalert device in two differents patterns of treatment, fixed combination of travoprost 0,004%/timolol 0,5% and concomitant combination of 0,004% and timolol 0,5%. )
    E.2.2Secondary objectives of the trial
    1.Valorar la seguridad de la combinación fija travoprost 0.004%/timolol 0.5% (una vez al día) o el régimen concomitante de travoprost y timolol (dos veces al día) durante un año de tratamiento.
    2. Valorar la eficacia de la combinación fija de travoprost/timolol (una vez al día) o el régimen concomitante de travoprost 0.0004% y timolol 0.5% (dos veces al día) durante 1 año de tratamiento
    3.Medir la satisfacción del paciente dependiendo de la medicación administrada cuando se aplica con el aparato Travalert®.
    4.Identificar los factores clínico-epidemiológicos asociados con la adherencia de los pacientes y las variables de seguridad.

    1. Evaluate the safety of the medication 2. Evaluate the efficacy of the medication.
    3. Patient Satisfaction depending on the group medication when using Travalert®.
    4. Identification of the clinical epidemiological factors associated with compliance and safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Pacientes adultos mayores de 18 años (mujeres o hombres) diagnosticados de glaucoma de ángulo abierto (con o sin componente pseudoexfoliativo) o con hipertensión ocular.
    2- Pacientes insuficientemente controlados en monoterapia con beta-bloqueantes o prostaglandinas que inicien tratamiento con una combinación (fija o no fija) de travoprost 0.004% y timolol 0.5%.
    3- Pacientes con las dos características siguientes de la presión intraocular en la visita de selección:
    • Una media de PIO en al menos uno de los ojos ≥ 19 mmHg
    • Una media de PIO en ningún ojo < 36 mmHg.

    4- El paciente debe satisfacer todos los requerimientos del Consentimiento Informado (una copia del consentimiento informado firmada y fechada se quedará en el Archivo del investigador y la otra será remitida al paciente).

    (Inclusion criteria
    1-Adult patient diagnosed with open-angle glaucoma or ocular hypertension.
    2-Patients not properly treated with one beta-blocker or prostaglandin analog monotherapy that begins with a combination (fix or not fix) of travoprost and timolol treatment.
    3-Patient must meet the following IOP entry criteria in at least one treated eye:
    •The mean IOP for the qualifying treated eye must be ≥ 19 mmHg
    •The mean IOP in either eye must not be greater than 36 mmHg.
    4-Patient satisfying all Informed Consent requirements)
    E.4Principal exclusion criteria
    -Mujeres en edad fertil están excluidas de la participación del estudio cuando no estén tomando medidas anticonceptivas adecuadas, cuando estén embarazadas o pretendan quedarse embarazadas durante el periodo del estudio.
    -Pacientes que en la actualidad no estén recibiendo tratamiento con prostaglandinas o betabloqueantes para disminuir la PIO.
    -Pacientes con otra patología relacionada con el incremento de la presión intraocular distinta al glaucoma de ángulo abierto o hipertensión ocular.
    -Pacientes que están o hayan estado en terapia con otro principio activo en investigación dentro de los 30 días anteriores de la visita de selección.
    -Alguna enfermedad inflamatoria del ojo crónica o recurrente en cualquiera de los ojos.
    -Trauma ocular dentro de los últimos seis meses en cualquier ojo.
    -Infección ocular o inflamación ocular dentro de los 3 últimos meses en cualquier ojo.
    -Enfermedad retiniana clínicamente significativa o progresiva como, degeneración retiniana, retinopatía diabética o desprendimiento de retina en cualquier ojo.
    -Cualquier otra patología severa ocular en cualquier ojo que pudiera impedir la administración de un análogo de prostaglandina tópica.
    -Hipersensibilidad severa o seria a prostaglandina o sus análogos, beta-bloqueantes sistémicos o tópicos o a cualquier componente de la medicación del estudio.
    -Cirugía intraocular en los últimos 6 meses.
    -Cirugía ocular con láser en los últimos 3 meses.
    -Anormalidades en cualquier ojo que no permita realizar una tonometría de una manera fiable.
    -Una puntuación en la agudeza visual corregida peor de 20/30 (6/9 metros y 0,66 en escala decimal) en el tablero de Snellen en cualquiera de los ojos.
    -Un grado angular menor a grado 2 en cualquiera de los ojos, medido por gonioscopio (ángulo estrecho con cierre parcial o completo).
    -Pacientes a los que no se le pueda discontinuar con seguridad la medicación crónica con glucocorticoides durante un periodo de 4 semanas.
    -Uso de cualquier medicación ocular hipotensiva adicional tópica o sistémica durante el estudio.
    -Enfermedad severa, inestable o incontrolable cardiovascular, hepática o renal.
    -Asma bronquial o enfermedad obstructiva crónica severa que podría evitar la administración segura de un beta-bloqueante tópico.
    -Menos de 30 días de régimen estable antes de la visita de selección de cualquier medicación o sustancia que no sea para la terapia del glaucoma, administradas por cualquier vía de administración y utilizada de manera crónica que podría afectar la presión intraocular.

    (Exclusion criteria
    -Females of childbearing potential are excluded from participation in the study when they do not take control measures to prevent it or are currently pregnant, or are breast-feeding.
    - Patient who is not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs or pateients with any form of glaucoma other than open-angle glaucoma or ocular hypertension.
    -Patient who is currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit
    -Chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye.
    -Clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue.
    -Cevere or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication.
    -Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye.
    -Any abnormality preventing reliable applanation tonometry of either eye.
    - Patient with best-corrected visual acuity worse than 20/30 (6/9 m or 0.66 decimal scale) on the Snellen scale in either eye.
    -Patient with angle grade less than Grade 2 in either eye, as measured by gonioscopy
    -Patient that have not passed a wash out period of chronic glucocorticoid medications (4 weeks), or intermittent glucocorticoid medications (2 weeks) and must be able to remain off these medications for the duration of the study.
    -Use of any additional topical or systemic ocular hyposensitive medication during the study.
    -Severe, unstable or uncontrolled cardiovascular, hepatic or renal disease or history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
    -Less that 30 days stable dosing regimen before the baseline visit of any NON-GLAUCOMA medications or substances administered by any route and used on a chronic basis that may affect IOP.



    E.5 End points
    E.5.1Primary end point(s)
    Adherencia del paciente medida con un cuestionario de valoración de la adherencia y el software del aplicador Travalert®.

    The primary objective is to compare patients adherence using Travalert® device in the different treatment groups. The measures are Travalert® software device records and compliance test.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    compliance
    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 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 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.8.3 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 concerned5
    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 Information not present in EudraCT
    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
    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 months3
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    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 state92
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    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 Decision2007-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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