Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-005222-29
    Sponsor's Protocol Code Number:LT2347-PIII-12/13
    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:2014-08-06
    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 number2013-005222-29
    A.3Full title of the trial
    Efficacy and Safety assessment of fixed combination unpreserved Latanoprost eye drops and Timolol 0.5% (T2347) versus Xalacom® in ocular hypertensive or glaucomatous patients.

    Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients
    Evaluación de la eficacia y seguridad del colirio de combinación fija de latanoprost y timolol al 0,5% sin conservantes (T2347) frente a Xalacom® en pacientes con hipertensión ocular o glaucoma
    Estudio de fase III, internacional, multicéntrico, aleatorizado, enmascarado para el investigador, de 3 meses de duración, con 2 grupos paralelos, 2 x 97 pacientes evaluables
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the tolerance and efficacy of T2347 in patients with glaucoma or ocular hypertension, stabilized with Xalacom® or generics
    Evaluación de la eficacia y seguridad del colirio de combinación fija de latanoprost y timolol al 0,5% sin conservantes (T2345) frente a Xalacom® en pacientes con hipertensión ocular o glaucoma
    A.4.1Sponsor's protocol code numberLT2347-PIII-12/13
    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 SponsorLaboratoires THÉA
    B.1.3.4CountryFrance
    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 supportLaboratoires Thea
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratoires Thea
    B.5.2Functional name of contact pointResearch and Development Department
    B.5.3 Address:
    B.5.3.1Street Address12 rue Louis Blériot
    B.5.3.2Town/ cityClermont Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number34934766810126
    B.5.5Fax number34934766811
    B.5.6E-maill.bresson@laboratoires-thea.fr
    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.3.2Product code T2347 (latanoprost 0.005% + timolol 0.5%)
    D.3.4Pharmaceutical form Eye drops, solution in single-dose container
    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 INNTimolol
    D.3.9.3Other descriptive nameTIMOLOL
    D.3.9.4EV Substance CodeSUB11069MIG
    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 INNLatanoprost
    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 typeequal
    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 Xalacom®
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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, solution
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    glaucoma and ocular hypertension
    Glaucoma e hipertensión ocular
    E.1.1.1Medical condition in easily understood language
    over tension in the eye
    Un incremento en la presión dentro del ojo
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    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
    The first objective of the study is to demonstrate the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye.
    El objetivo principal del estudio es demostrar la no inferioridad del colirio sin conservantes T2347 frente a Xalacom® en el cambio en la PIO media del ojo más afectado a las 9:00 h (± 1 hora) entre el inicio (Día 0) y el Día 84
    E.2.2Secondary objectives of the trial
    The secondary objective is the evaluation of the efficacy and safety by mean of secondary efficacy and safety criteria. Those criteria are explicitly mentioned in the study protocol.
    El objetivo secundario es la evaluación de la eficacia y la seguridad mediante los criterios de eficacia y seguridad secundarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient will be eligible for inclusion in this study if all these criteria are respected at the inclusion visit:
    - Signed and dated informed consent,
    - Male or female aged ? 18 years old,
    - Both eyes with open angle glaucoma or ocular hypertension already treated and controlled by Xalacom® or generics since at least 2 months.
    - IOP ? 18 mmHg in both eyes
    -- History of IOP insufficiently controlled with first-line monotherapy based on the investigator judgement (e.g. non reaching the target IOP)
    - History of an add-on IOP reduction with Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops) in comparison with first-line treatment
    - Corneal thickness ? 500 ?m and ? 600 ?m in both eyes.
    - Consentimiento informado firmado y fechado
    - Hombre o mujer de ? 18 años
    - Ambos ojos con glaucoma de ángulo abierto o hipertensión ocular ya tratada y controlada con Xalacom® o genéricos (combinación fija de latanoprost al 0,005% y timolol al 0,5% con conservantes) desde al menos 2 meses
    - PIO ? 18 mm Hg en ambos ojos
    - Antecedentes de PIO controlada de forma insuficiente con tratamiento monoterapia de primera elección basado en el juicio del investigador (e.i. no se ha conseguido el nivel de PIO deseada)
    - Antecedentes de haberse obtenido una reducción adicional de los valores de PIO con Xalacom® o genéricos (colirio en base a una combinación fija de latanoprost 0.005% + timolol 0.5% con conservantes) en comparación con el tratamiento de primera elección.
    - Espesor corneal ? 500 ?m y ? 580 ?m en ambos ojos
    E.4Principal exclusion criteria
    Ophthalmic exclusion criteria (in either eye)
    - Fundoscopy not performed or not available within the 6 months before inclusion visit.
    - Visual field (VF) not performed or not available within the 6 months before inclusion visit.
    - Significant worsening according to the two last VF (minimum 6 months between these 2 VF)
    - Advanced stage of glaucoma:
    ? Absolute defect in the ten degrees central point of the visual field.
    ? Severe visual field loss according to the investigator?s best judgement.
    ? Risk of visual field worsening as a consequence of participation in the trial according to the investigator?s best judgement.
    - Best far corrected visual acuity ? 1/10.
    - History of trauma, infection, clinically significant inflammation within the 3 months before inclusion visit.
    - Ongoing or known history of ocular seasonal and perennial allergy (SAC, PAC) and/or uveitis and/or viral infection.
    - Presence of at least one severe objective sign among the following:
    ? Hyperaemia (Grade 5)
    ? Superficial punctate keratitis (Grade 3)
    ? Blepharitis (Grade 3)
    - Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day).
    - Corneal ulceration.
    - Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.
    - History of corneal refractive surgery.
    - Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination or corneal refractive surgery.

    The protocol also defines other exclusion criteria such as systemic/non ophthalmic exclusion criteria, specific exclusion criteria for women, exclusion criteria related to general conditions and exclusion criteria related to previous and concomitant medications/ non-product therapies.
    Criterios de exclusión oftálmicos (en cualquier ojo)
    - Oftalmoscopia no realizada o no disponible en los 6 meses previos a la visita de inclusión
    - Examen del campo visual (CV) no realizado o no disponible en los 6 meses previos a la visita de inclusión
    - Empeoramiento significativo según los dos últimos exámenes del CV (intervalo mínimo de 6 meses entre cada uno)
    - Estadio avanzado del glaucoma:
    ? Defecto absoluto en los diez grados centrales del campo visual
    ? Pérdida grave del campo visual según el mejor criterio del investigador
    ? Riesgo de empeoramiento del campo visual como consecuencia de la participación en el estudio según el mejor criterio del investigador
    - Mejor agudeza visual corregida de lejos ? 1/10
    - Antecedentes de traumatismo, infección, inflamación clínicamente significativa en los 3 meses previos a la visita de inclusión
    - Presencia o antecedentes conocidos de conjuntivitis alérgica estacional o perenne (CAE, CAP), uveítis y/o infección vírica
    - Presencia de al menos uno de los siguientes signos objetivos graves:
    ? Hiperemia (grado 5)
    ? Queratitis punteada superficial (grado 3)
    ? Blefaritis (grado 3)
    - Sequedad ocular grave (definida como erosiones epiteliales graves de la córnea y/o uso de medicamentos para el ojo seco con una frecuencia superior a 8 instilaciones/día)
    - Úlcera corneal
    - Anomalías palpebrales no relacionadas con el tratamiento del estudio e incompatibles con una buena evaluación
    - Antecedentes de cirugía refractiva de la córnea
    - Cualquier anomalía que impida una evaluación precisa, por ejemplo, una medición por tonometría fiable o un examen del campo visual

    El protocolo también define otros criterios de exclusión tales como criterios sistémicos/no oftálmicos, criterios de exclusión específicos para pacientes de sexo femenino, los relacionados con la medicación/terapias no medicamentosas concomitante tanto a nivel sistémico como ocular, y criterios de exclusión relacionados con la condición médica general del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline in mean IOP (average of the 2 or 3 recording values) on Day 84 in the worse eye.
    La variable principal de eficacia es el cambio del valor promedio de la presión intraocular (promedio de 2 ó 3 medidas)en D84, respecto al valor basal, en el peor ojo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    Día 84
    E.5.2Secondary end point(s)
    Secondary key efficacy variables:
    - Change from baseline in mean IOP
    - Global assessment of efficacy by the investigator
    Variables secundarias de eficacia:
    -Cambio de la media de la presión intraocular respecto al valor basal
    -Evaluación global de la eficacia del tratamiento realizada por el investigador
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 42 and day 84
    Día 42 y Día 84
    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 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Patient Last Visit (LPLV)
    Último paciente Última Visita
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 210
    F.4.2.2In the whole clinical trial 210
    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 Decision2014-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-20
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 09 13:11:13 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA