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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43724   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2005-004767-34
    Sponsor's Protocol Code Number:C-05-25
    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:2006-02-17
    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 number2005-004767-34
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble enmascarado de seis semanas para evaluar la eficacia y seguridad de la administración única por la mañana de Travoprost/Timolol comparada con la administración dos veces al día de Dorzolamida/Timolol en pacientes con glaucoma de ángulo abierto o hipertensión ocular.
    A.3.2Name or abbreviated title of the trial where available
    Travoprost 0.004%/Timolol 0.5% and Dorzolamide 2%/Timolol 0.5%
    A.4.1Sponsor's protocol code numberC-05-25
    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 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 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 Information not present in EudraCT
    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 0.004%/Timolol 0.5% Ophthalmic Solution
    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 IMPOphthalmic use (Noncurrent)
    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.3.9.2Current sponsor codeAL-6221
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(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
    D.3.9.1CAS number 26921-17-5
    D.3.9.2Current sponsor codeAL-1239
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name COSOPT
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 nameCOSOPT
    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 IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDorzolamide
    D.3.9.1CAS number 130693-82-2
    D.3.9.2Current sponsor codeAL-4217A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOphthalmic use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glaucoma de ángulo abierto e hipertensión ocular /
    Open-angle glaucoma and ocular hypertension
    MedDRA Classification
    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 de este estudio es comparar la eficacia para reducir la PIO y la seguridad de administrar Travoprost 0,004% / Timolol 0,5% Solución Oftálmica (administración única matinal) frente a Dorzolamida 2% / Timolol 0,5% Solución Oftálmica, administrada dos veces al día, en pacientes con glaucoma de ángulo abierto o hipertensión ocular. / The primary objective of this study is to compare the IOP-lowering efficacy and safety of dosing of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (once-daily morning dosing) vs. Dorzolamide 2%/Timolol 0.5% Ophthalmic Solution, dosed twice-daily, in patients with open-angle glaucoma or ocular hypertension.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    •Pacientes hombres o mujeres de 18 años de edad o mayores a quienes se les haya diagnosticado glaucoma de ángulo abierto (con o sin pseudoexfoliación o componente de dispersión del pigmento) o hipertensión ocular, que actualmente estén recibiendo tratamiento con uno o más hipotensores oculares y que, en opinión del investigador, se beneficiarían del uso de una de las politerapias.
    •Los pacientes deberán cumplir los siguientes criterios de inclusión con respecto a la PIO en al menos un ojo tratado: (1) Para que el(los) ojo(s) tratado(s) resulte(n) apto(s) su PIO media debe ser superior o igual a 24 mmHg a las 9 AM en las visitas de Elegibilidad 1 y 2. (2) Para que el(los) ojo(s) tratado(s) resulte(n) apto(s), su PIO media debe ser superior o igual a 21 mmHg a las 4 PM en las visitas de Elegibilidad 1 y 2. (3) El valor medio de la PIO de cualquiera de los ojos en las visitas de Elegibilidad 1 y 2 no deberá ser superior a 36 mmHg en ninguna de las dos horas. (4)El(los) mismo(s) ojo(s) deberá(n) resultar apto(s) en ambas horas en las visitas de Elegibilidad 1 y 2..
    •Los pacientes deberán poder interrumpir el uso de cualquier medicación para reducir la PIO durante un período mínimo de 5 días ± 1 día a un período de 28 días ± 1 día antes de la visita de Elegibilidad 1.
    •Sólo se podrán incluir en el estudio a aquellos pacientes que cumplan todos los requisitos del consentimiento informado.
    E.4Principal exclusion criteria
    •Las mujeres en edad fértil (que no se hayan sometido a una esterilización quirúrgica como mínimo 3 meses antes del inicio del estudio o que lleven como mínimo dos años en período postmenopáusico) no podrán participar en el estudio si actualmente están embarazadas o n período de lactancia o nestán utilizando métodos anticonceptivos altamente eficaces.
    •Pacientes que presenten cualquier forma de glaucoma que no sea glaucoma de ángulo abierto o hipertensión ocular.
    •Pacientes que actualmente reciban terapia o que estuvieron recibiendo terapia con otro fármaco en investigación dentro de los 30 días anteriores a la visita de Elegibilidad 1.
    •Antecedentes de enfermedades oculares inflamatorias graves, crónicas, recurrentes o actuales (por ejemplo, escleritis, uveítis, queratitis herpética) en cualquiera de los dos ojos.
    •Antecedentes de o padecer actualmente cualquier otra patología ocular grave (incluido ojo seco grave) en cualquiera de los dos ojos que impediría la administración de un análogo de la prostaglandina, inhibidor de la anhidrasa carbónica o betabloqueante por vía tópica.
    •Pacientes en quienes no sea posible interrumpir sin riesgo el uso de cualquier medicamento glucocorticoide administrado por cualquier vía.
    •Antecedentes de hipoglucemia espontánea o actual o diabetes no controlada.
    •Cualquier anomalía que impida realizar una tonometría de aplanación fiable en cualquiera de los dos ojos.
    •Antecedentes de o padecer actualmente enfermedades retinianas progresivas o clínicamente relevantes.
    •Antecedentes de traumatismos o cirugía intraoculares en los últimos seis meses.
    •Pacientes con una pauta de administración estable de menos de 30 días antes de la Visita de Selección con cualquier medicamento o sustancia NO ANTIGLAUCOMATOSA .
    •Antecedentes de o padecer actualmente asma bronquial, enfermedad pulmonar obstructiva crónica grave, o enfermedad grave cardiovascular, hepática o renal inestable o no controlada.
    •Pacientes que presenten una mejor agudeza visual corregida peor que una puntuación 0,6 logMAR en cualquiera de los dos ojos.
    •Pacientes con una amplitud del ángulo inferior a Grado 2 medido por gonioscopia.
    •Pacientes con un índice copa/disco superior a 0,80 en cualquiera de los dos ojos.
    •Además, el Monitor Médico podrá declarar a un paciente no apto debido a una razón médica válida.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo estadístico principal de este estudio es demostrar que la eficacia para reducir la PIO de Travoprost 0,004% / Timolol 0,5% Solución Oftálmica (administración única matinal) es superior a la de Dorzolamida 2% / Timolol 0,5% Solución Oftálmica, administrada dos veces al día.
    The primary statistical objective of this study is to demonstrate that the IOP-lowering efficacy of dosing Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (once-daily morning dosing) is superior to Dorzolamide 2%/Timolol 0.5% Ophthalmic Solution, dosed twice-daily.
    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 Information not present in EudraCT
    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 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) 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-02-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 450
    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)
    Tratamiento estándar
    standard therapy
    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 Decision2006-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
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