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   43851   clinical trials with a EudraCT protocol, of which   7283   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:2016-000176-20
    Sponsor's Protocol Code Number:GLJ576-P001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-000176-20
    A.3Full title of the trial
    Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV)
    Efficacité et tolérance de l’association Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) administrée 2 fois par jour en supplément d’un traitement par l’association Travoprost 0.004% / Timolol 0.5% (DUOTRAV).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the combined effect of Simbrinza with another eye medication on Glaucoma
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of Simbrinza as an Adjunctive to DuoTrav
    A.4.1Sponsor's protocol code numberGLJ576-P001
    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 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 supportAlcon Research Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlcon Eye Care (UK) Ltd
    B.5.2Functional name of contact pointEMEA Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressRiverside Way, Watchmoor Park
    B.5.3.2Town/ cityCamberley
    B.5.3.3Post codeGU15 3YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailemea.ra@alcon.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 Yes
    D.2.1.1.1Trade name Simbrinza
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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, suspension
    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 INNBrinzolamide
    D.3.9.1CAS number 138890-62-7
    D.3.9.4EV Substance CodeSUB05892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrimonidine
    D.3.9.1CAS number 59803-98-4
    D.3.9.4EV Substance CodeSUB05889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboEye drops, suspension
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ocular Hypertension
    Open-angle Glaucoma
    Hypertension occulaire
    Glaucome à angle ouvert
    E.1.1.1Medical condition in easily understood language
    Increased pressure in the eye
    Glaucoma
    Augmentation de la pression dans l'oeil
    Glaucome
    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 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 demonstrate the additive IOP lowering effect of Brinzolamide 1%/Brimonidine 0.2% (dosed BID) when added to Travoprost 0.004%/Timolol 0.5% solution in subjects with open-angle glaucoma or ocular hypertension
    Mettre en évidence l’effet additif de l’association Brinzolamide 1 % / Brimonidine 0,2 % (administrée deux fois/jour) dans la baisse de la PIO lorsqu’elle est ajoutée à une solution de Travoprost 0,004 % / Timolol 0,5 % chez des patients présentant un glaucome à angle ouvert ou une hypertension oculaire.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension
    - Currently on treatment with Travoprost 0.004%fTimolol 0.5% prescribed as approved in the country, on evening dosing for at least 28 days prior to screening, and In the opinion of the Investigator may benefit from further lOP lowering
    - Mean lOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ≥ 21 and ≤ 28 mmHg at 9:00 while on a Travoprost 0.004%/ Timolol 0.5% solution)
    - Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee
    - Willing and able to attend all study visits
    - Other protocol-defined inclusion criteria may apply
    - Diagnostic de glaucome à angle ouvert (y compris un glaucome à angle ouvert avec pseudo-exfoliation ou dispersion pigmentaire) ou d’hypertension oculaire
    - Sujets actuellement sous traitement par travoprost 0,004 % / timolol 0,5 % prescrit selon l’indication autorisée dans le pays, en administration le soir pendant au moins 28 jours avant la sélection et qui, de l’avis de l’investigateur, pourraient tirer profit d’un abaissement supplémentaire de la PIO
    - Mesures de la PIO moyenne de qualification à la fois lors des visites d’admissibilité 1 et 2 dans au moins 1 œil (le même œil / les mêmes yeux ≥ 21 et ≤ 28 mmHg à 9 h lorsque le sujet est sous traitement avec la solution de travoprost 0,004 % / timolol 0,5 %)
    - Le sujet doit être en mesure de comprendre et de signer un formulaire de consentement éclairé, approuvé par un Comité de protection des personnes/Comité d’éthique indépendant
    - Le sujet doit être disposé à se rendre à toutes les visites de l’étude et en mesure de le faire.
    - Tout autre critère d'inclusion défini dans le protocole
    E.4Principal exclusion criteria
    - Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
    - Any form of glaucoma other than open-angle glaucoma or ocular hypertension
    - Severe central visual field loss in either eye
    - Chronic, recurrent or severe Inflammatory eye disease In either eye
    - Ocular trauma in either eye within the past 6 months prior to the Screening visit
    - Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit
    - Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye
    - Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye
    - Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication
    - Intraocular surgery in either eye within the past 6 months prior to the Screening visit
    - Ocular laser surgery in either eye within the past 3 months prior to the Screening visit
    - Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study
    - Asthma, history of asthma, or severe chronic obstructive pulmonary disease
    - Other protocol-defined exclusion criteria may apply
    - Les femmes en âge de procréer (Women of Childbearing Potential, WOCBP), c’est-à-dire toutes les femmes qui ne sont pas ménopausées depuis au moins 1 an ou qui sont stérilisées depuis moins de 6 semaines, actuellement enceintes, ou qui ont un test de grossesse positif lors de la visite de sélection, ou elles prévoient une grossesse au cours de l’étude ; elles allaitent, ou elles ne consentent pas à utiliser des méthodes de contraception adéquates afin d’éviter une grossesse pendant toute la durée de l’étude.
    - Les sujets présentant toute forme de glaucome autre que le glaucome à angle ouvert ou l’hypertension oculaire.
    - Les sujets présentant une perte de champ visuel central aggravée dans l’un ou l’autre œil
    - Les sujets présentant une maladie oculaire inflammatoire chronique, récurrente ou grave dans l’un ou l’autre œil
    - Les sujets présentant un traumatisme oculaire dans l’un ou l’autre œil dans les 6 mois précédant la visite de sélection.
    - Les sujets ayant une infection oculaire ou inflammation oculaire dans l’un ou l’autre œil au cours des 3 mois précédant la visite de sélection.
    - Les sujets ayant une dégénérescence rétinienne, une rétinopathie diabétique ou un décollement de la rétine dans l’un ou l’autre œil.
    - Les sujets ayant un score d’acuité visuelle corrigée inférieur à 55 lettres ETDRS (équivalent à environ 20/80 sur l’échelle de Snellen, 0,60 logMAR ou 0,25 décimal) dans l’un ou l’autre œil.
    - Les sujets présentant une pathologie oculaire (y compris une sécheresse oculaire sévère) dans l’un ou l’autre œil qui peut, de l’avis de l’investigateur, empêcher l’administration en toute sécurité de tout médicament à l’étude.
    - Les sujets ayant subi une chirurgie intraoculaire dans l’un ou l’autre œil au cours des 6 mois précédant la visite de sélection
    - Les sujets ayant subi une chirurgie oculaire au laser dans l’un ou l’autre œil réalisée dans les 3 mois précédant la visite de sélection
    - Toute autre pathologie (y compris une maladie grave) qui, selon l’investigateur, contre-indiquerait la participation à l’étude du sujet
    - Les sujets à l’étude atteints d’asthme, ayant des antécédents d’asthme ou souffrant de bronchopneumopathie chronique obstructive grave.
    - Tout autre critère d'exclusion défini dans le protocole
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in Diurnal lOP at Week 6
    Modification par rapport à la visite de référence de la PIO diurne à la Semaine 6
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    Semaine 6
    E.5.2Secondary end point(s)
    - Diurnal lOP at Week 6
    - Percentage Change from Baseline in Diurnal lOP at Week 6
    - Change from Baseline in lOP for Each Time Point (09:00, 11 :00, 15:00) at Week 6
    - Percentage Change from Baseline in lOP for Each Time Point (09:00, 11 :00, 15:00) at Week 6
    - PIO diurne moyenne à la Semaine 6
    - Modification en pourcentage par rapport à la visite de référence de la PIO diurne à la Semaine 6
    - Modification par rapport à la visite de référence de la PIO pour chaque point temporel (9 h, 11 h et 15 h) à la Semaine 6
    - Modification en pourcentage par rapport à la visite de référence de la PIO pour chaque point temporel (9 h, 11 h et 15 h)
    à la Semaine 6
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 6
    Semaine 6
    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) 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 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) No
    E.8.2.2Placebo Yes
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Argentina
    Australia
    Chile
    Colombia
    Korea, Republic of
    Taiwan
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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)
    Not different from the expected normal treatment for the condition
    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 Decision2016-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-19
    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-Sat Apr 20 04:22:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA