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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2015-003631-34
    Sponsor's Protocol Code Number:192024-095
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2016-11-08
    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 number2015-003631-34
    A.3Full title of the trial
    A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension
    Una comparación de Bimatoprost LP con trabeculoplastia selectiva con láser en pacientes con glaucoma de ángulo abierto o hipertensión ocular
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare a slow release formulation of bimatoprost with selective laser trabeculoplasty in patients with open-angle glaucoma or high pressure in the eye
    Un estudio para comparar una formulación de Bimatoprost de liberación prolongada con trabeculoplastia selectiva con láser en pacientes con glaucoma de ángulo abierto o hipertensión ocular
    A.4.1Sponsor's protocol code number192024-095
    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 SponsorAllergan Limited
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34913913443
    B.5.5Fax number+441628494449
    B.5.6E-mailml-ctrg@allergan.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 nameBimatoprost SR
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracameral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboOphthalmic insert
    D.8.4Route of administration of the placeboIntracameral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Open-angle glaucoma (OAG) or Ocular hypertension (OHT)
    Glaucoma de ángulo abierto (GAA) o Hipertensión ocular (HO)
    E.1.1.1Medical condition in easily understood language
    Glaucoma and increased pressure inside the eye (ocular hypertension)
    Glaucoma y aumento de la presión intraocular (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 19.0
    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 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 evaluate the IOP-lowering effect and safety of Bimatoprost SR compared with SLT in patients with OAG or OHT, who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
    Evaluar el efecto reductor de la presión intraocular (PIO) y la seguridad de Bimatoprost LP, en comparación con la trabeculoplastia selectiva con láser (TSL), en pacientes con glaucoma de ángulo abierto (GAA) o hipertensión ocular (HO) no controlados adecuadamente con medicamentos tópicos para la reducción de la PIO por causas distintas a la eficacia de la medicación (es decir, no se debe a intolerancia ni a incumplimiento terapéutico)
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 18 years of age or older;
    2. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (e.g., Written Authorization for Use and Release of Health and Research Study Information [United States (US) sites] and written Data Protection consent [European Union (EU) sites])
    3. In the investigator’s opinion, patient’s IOP is not adequately managed with topical medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence)

    Both Eyes
    1. In the investigator’s opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (e.g., LUMIGAN, Xalatan®, Travatan®) eye drops as the sole therapy if medication was taken as directed;
    2. In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy;
    3. In the investigator’s opinion, patient is a suitable candidate for SLT;
    4. Diagnosis of either OAG (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, requiring bilateral IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes);
    5. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout;
    6. The iridocorneal angle inferiorly must be confirmed as being qualified by Reading Center anterior segment optical coherence tomography assessment prior to beginning Washout;
    7. At the Baseline visit (8:00 AM ± 1 hour), IOP of >/= 22 and </= 34 mm Hg, with difference between eyes of </= 5 mm Hg.
    1. Hombre o mujer de 18 años de edad o mayor
    2. Se obtienen el consentimiento informado escrito y la autorización para utilizar y divulgar información sanitaria personal de conformidad con los requisitos de privacidad locales y nacionales, cuando proceda (p. ej. autorización escrita para el uso y la divulgación de información sanitaria y del estudio de investigación [centros de Estados Unidos (EE. UU.)] y consentimiento de protección de datos por escrito [Unión Europea (UE)])
    3. En opinión del investigador, la PIO del paciente no está controlada adecuadamente con la medicación tópica por causas distintas a la eficacia de la medicación (ej, debido a intolerancia o al incumplimiento terapéutico)

    Ambos ojos
    1. En opinión del investigador, ambos ojos pueden tratarse adecuadamente con colirios de prostamida, prostaglandina o análogo de las prostaglandinas (p. ej., LUMIGAN, Xalatan, Travatan), como único tratamiento si la medicación se toma del modo indicado;
    2. En opinión del investigador, la PIO del paciente puede controlarse adecuadamente con monoterapia con TSL;
    3. En opinión del investigador, el paciente es un candidato idóneo para la TSL;
    4. Diagnóstico de GAA (es decir, GAA primaria, glaucoma pseudoexfoliativo, glaucoma pigmentario) o HO en ambos ojos, requiriéndose tratamiento bilateral reductor de la PIO. (Nota: el diagnóstico no tiene que ser necesariamente el mismo para ambos ojos);
    5. Densidad de células endoteliales centrales por microscopia especular confirmada como apta mediante la evaluación en el Centro de lectura antes de iniciarse el reposo farmacológico;
    6. Debe confirmarse que el ángulo iridocorneal inferior es apto mediante la evaluación por tomografía de coherencia óptica del segmento anterior en el Centro de lectura, antes de iniciarse el reposo farmacológico;
    7. En la visita inicial (08:00 ± 1 hora), PIO >/= 22 y </= 34 mm Hg, con diferencia entre ojos </= 5 mm Hg
    E.4Principal exclusion criteria
    Both Eyes
    • History of previous laser trabeculoplasty
    • History of cataract surgery resulting in anterior chamber (AC) intraocular lens (IOL) implant, phakic IOL, sulcus IOL, aphakia, or complications (e.g., a posterior capsular tear [with or without vitreous loss], iris trauma, etc.)
    Ambos ojos
    • Antecedentes de trabeculoplastia con láser previa
    • Antecedentes de cirugía para cataratas que resultase en implante de lente intraocular (LIO) en la CA, LIO fáquica, LIO en surco, afaquia o complicaciones (p. ej., ruptura de cápsula posterior [con o sin pérdida vítrea], traumatismo del iris, etc.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is IOP change from baseline and the primary time period is 24 weeks
    La variable principal de la eficacia es la variación de la PIO con respecto al inicio, siendo el período de tiempo principal de 24 semanas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 4, 12, and 24
    Semanas 4, 12 y 24
    E.5.2Secondary end point(s)
    Secondary efficacy variables to compare Bimatoprost SR eyes and SLT eyes include:
    1) IOP change from baseline time-weighted average through Week 24
    2) IOP changes from baseline at Weeks 8, 15, and 20
    3) Raw IOP at each visit
    4) Time to onset of effect (time to first achieving >/= 20% IOP reduction)
    5) Time to initial use of nonstudy IOP-lowering treatment (as determined by the investigator)
    6) Percentage of Bimatoprost SR and SLT eyes achieving >/= 20% reduction by visit
    Las variables secundarias de la eficacia para comparar los ojos con Bimatoprost LP y con TSL incluyen:
    1) Variación de la PIO en la semana 24 con respecto a la media inicial ponderada por tiempo
    2) Las variaciones de la PIO en las semanas 8, 15 y 20 con respecto al inicio
    3) PIO bruta de cada visita
    4) Tiempo hasta el inicio del efecto (tiempo transcurrido hasta alcanzar por primera vez una reducción de la PIO >/= 20%)
    5) Tiempo hasta el uso inicial de medicamentos reductores de la PIO no pertenecientes al estudio (como lo determine el investigador)
    6) Porcentaje de ojos con Bimatoprost LP o TSL que alcanzan una reducción >/= 20% por visita
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 5) - Study duration
    2) - Weeks 8, 15, and 20
    3), 6) - Each visit
    4) - Time to first achieving >/= 20% IOP reduction
    1), 5) -Duración del estudio
    2) - Semanas 8, 15 y 20
    3), 6) - Cada visita
    4) - tiempo transcurrido hasta alcanzar por primera vez una reducción de la PIO >/= 20%
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Paired eye, masked
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    360° SLT
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Belgium
    Czech Republic
    France
    Italy
    Poland
    Russian Federation
    Singapore
    Spain
    Thailand
    United States
    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
    The End of trial is defined by the last patient last visit (LPLV).
    El fin de ensayo se define como la última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days30
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 160
    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)
    Subjects will return to their standard of care treatment as determined by their physician after completion of the trial
    Los sujetos volverán a su tratamiento habitual según las indicaciones de su médico una vez finalizado el estudio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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