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    Summary
    EudraCT Number:2017-002588-17
    Sponsor's Protocol Code Number:SAM-IIT01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-002588-17
    A.3Full title of the trial
    Safety and effects on visual function of 0.01% Atropin eye drops for myopia inhibition in children and adolescents
    Sicherheit und Auswirkungen auf die Sehfunktion von 0,01% Atropin-Augentropfen zur Myopie-Hemmung bei Kindern und Jugendlichen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and effects on visual function of 0.01% Atropin eye drops for inhibition of nearsightedness in children and adolescence
    Sicherheit und Auswirkungen auf die Sehfunktion von 0,01% Atropin-Augentropfen zur Hemmung von Kurzsichtigkeit bei Kindern und Jugendlichen
    A.4.1Sponsor's protocol code numberSAM-IIT01
    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 SponsorUniversitätsklinikum Tübingen
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Hospital Tübingen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Tübingen
    B.5.2Functional name of contact pointFocke Ziemssen
    B.5.3 Address:
    B.5.3.1Street AddressElfriede-Aulhorn-Straße 7
    B.5.3.2Town/ cityTübingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number4970712984762
    B.5.5Fax number497071295021
    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 nameAtropin 0.01%
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation Yes
    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
    Myopia
    Myopie
    E.1.1.1Medical condition in easily understood language
    Nearsightedness
    Kurzsichtigkeit
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    To assess the amplitude of accommodation
    Beurteilung der Akkommodationsbreite
    E.2.2Secondary objectives of the trial
    The investigation of treatment effects as reflected by clinical endpoints of visual functions, accommodation velocity, pupil reaction, choroidal thickness are secondary aims of the trial.
    Die Untersuchung von Behandlungsauswirkungen anhand der klinischen Endpunkte Sehfunktionen, Akkommodationsgeschwindigkeit, Pupillenverhalten, Aderhautdicke sind sekundäre Ziele der Studie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Children and adolescents for whom the decision was already made for treatment with 0.01% atropine based on their individual situation (eye length, observed myopia progression) and after thorough information discussion about the special status of the myopia. Determining indications for treatment and general consultation will be based on the recommendations of the scientific medical societies.
    • Age 6-17 years
    • Myopia progression of at least 0.5 dpt in the last 12 months in at least on eye
    • Myopia below 4.0 dpt
    • Written consent of at least one legal guardian and assent of the subject
    • Kinder und Jugendliche, bei denen die Entscheidung zu einer Behandlung mit 0,01% Atropin auf Grund der individuellen Situation (Augenlänge, beobachtete Progression der Myopie) nach einem ausführlichen Aufklärungsgespräch über den Sonderstatus der Myopie bereits getroffen wurde. Die Indikationsstellung und allgemeine Beratung orientiert sich an den Empfehlungen der wissenschaftlichen Fachgesellschaften.
    • Alter 6-17 Jahre
    • Myopieprogression mindestens 0,5 dpt in den vergangenen 12 Monaten auf mindestens einem Auge
    • Myopie unter 4,0 dpt
    • Schriftliches Einverständnis mindestens eines Erziehungsberechtigten und des/r Probanden/in
    E.4Principal exclusion criteria
    • Anisometropia > 1.0 dpt.
    • Astigmatism > 1.5 Dpt.
    • Best corrected vision < 0.8
    • Eye diseases other than myopia, in particular changes of the conjunctiva, scarring of the cornea and diseases of the anterior segment of the eye
    • Known intolerance of atropine eye drops
    • Participation in another clinical trial within the last 30 days
    • Anisometropie > 1,0 dpt.
    • Astigmatismus > 1,5 Dpt.
    • Bestkorrigierter Visus < 0,8
    • Erkrankungen des Auges außer der Myopie, insbesondere Veränderungen der Bindehaut, Narben der Hornhaut und Erkrankungen des vorderen Augenabschnitts
    • Bekannte Unverträglichkeit auf Atropin-Augentropfen
    • Teilnahme an einer anderen klinischen Studie innerhalb der letzten 30 Tage
    E.5 End points
    E.5.1Primary end point(s)
    Amplitude of accommodation
    Akkommodationsbreite
    E.5.1.1Timepoint(s) of evaluation of this end point
    After end of study
    Nach Studienende
    E.5.2Secondary end point(s)
    Accommodation velocity
    Local tolerability
    Systemic tolerability
    Pupil diameter and reaction
    Contrast sensitivity
    Light/dark adaptation
    Glare sensitivity
    OCT angiography and EDI-OCT
    Anterior segment OCT
    Volume of the ciliary muscle
    Akkommodationsgeschwindigkeit
    Lokale Verträglichkeit
    Systemische Verträglichkeit
    Pupillendurchmesser und –reaktion
    Kontrastempfindlichkeit
    Hell-Dunkel-Adaption
    Blendungsempfindlichkeit
    OCT-Angiographie und EDI-OCT
    Vorderabschnitts-OCT
    Volumen des M.ciliaris
    E.5.2.1Timepoint(s) of evaluation of this end point
    After end of study
    Nach Studienende
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 2019-06-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state30
    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)
    The off-label treatment with 0.01 % atropine eye drops used in clinical routine is usually given for 2 years. The duration of the planned study is one year. After end of the study, it is planned to continue patient treatment with 0.01 % atropine eye drops for another year. 0.01 % atropine eye drops will either be prepared as extemporaneous mixture (according to the currently used approach outside of clinical trials) or, if available at that time, given as a licensed drug.
    Die in der klinischen Routine angewandte off-label-Therapie mit 0,01 % Atropin-Augentropfen zur Myopie-Hemmung beträgt üblicherweise 2 Jahre. Die Dauer der geplanten Studie ist ein Jahr. Es ist geplant, Patienten nach Ende der klinischen Studie für ein weiteres Jahr mit 0,01 % Atropin-Augentropfen, welche als Rezeptur hergestellt werden (entsprechend dem aktuellen Vorgehen außerhalb von Studien) oder aber, falls bis dorthin verfügbar, mit einem entsprechenden zugelassenen Präparat zu behandeln.
    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 Decision2019-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-09
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