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    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   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:2005-001976-12
    Sponsor's Protocol Code Number:DWP 815, 116.01.05
    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:2005-06-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-001976-12
    A.3Full title of the trial
    12-monatige, prospektive klinische Phase IV-Prüfung zur Untersuchung der lokalen und systemischen Verträglichkeit von Clonid-Ophtal® 1/8% AT versus Tim-Ophtal® 0,5% AT bei Patienten mit okulärer Hypertension oder Offenwinkelglaukom
    A.4.1Sponsor's protocol code numberDWP 815, 116.01.05
    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 SponsorDr. Winzer Pharma
    B.1.3.4CountryGermany
    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.2.1.1.1Trade name Clonid-Ophtal 1/8%
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Winzer Pharma
    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.3.1Product nameClonid-Ophtal 1/8%
    D.3.2Product code 815
    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 IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClonidinhydrochlorid
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1/8
    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 Tim-Ophtal 0,5%
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Winzer Pharma
    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.3.1Product nameTim-Ophtal 0,5%
    D.3.2Product code 116
    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 IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTimololhydrogenmaleat
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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 placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Offenwinkelglaukom oder okuläre 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
    Primäres Studienziel ist es, anhand der in dieser Studie gesammelten Daten die lokale und systemische Langzeitverträglichkeit von Clonid-Ophtal® 1/8% in den zugelassenen Indikationen zu untersuchen.
    E.2.2Secondary objectives of the trial
    Sekundäres Studienziel ist es, die Augeninnendruck-senkende Wirkung von Clonid-Ophtal® 1/8% AT zu dokumentieren.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Erkrankung beider Augen (nicht notwendigerweise symmetrisch ausgeprägt) mit folgenden Merkmalen und Behandlungsbedarf
    - Okuläre Hypertension (OHT)
    - Normaldruckglaukom (NDG)
    - Primär chronisches Offenwinkelglaukom (POWG)
    - Sekundäres Offenwinkelglaukom (wie z.B. Pigmentglaukom, Pseudoexfoliations- glaukom, postinflammatorisches Glaukom, Glaukom nach Contusio bulbi)
    - Intraokularer Druck (IOD) zwischen 12 und 28 mmHg (in beiden Augen)
    - Mündige, ambulante (oder stationäre) Frauen und Männer über 18 Jahre
    - Schriftliches Einverständnis zur Prüfungsteilnahme
    Es dürfen Patienten mit und ohne arterielle Hypertonie eingeschlossen werden.
    E.4Principal exclusion criteria
    1. Augen:
    - intraokulare Operation innerhalb der letzten 6 Monate vor Studienbeginn
    - okuläre Infektion und/oder Entzündung innerhalb eines Monats vor Studienbeginn
    - rezidivierende entzündliche Augenerkrankungen
    - dystrophische Störungen der Cornea
    - Tragen von Kontaktlinsen
    2. Herz-Kreislauf-System:
    - Bradykardie
    - Hypotonie
    - Gefäßsklerose
    - Sinusknotensyndrom
    - AV-Block II. und III. Grades
    - dekompensierte Herzinsuffizienz
    - kardiogener Schock
    3. Respirationstrakt:
    - schwere allergische Rhinitis
    - bronchiale Hyperreagibilität
    - bestehendes oder anamnestisch bekanntes Bronchialasthma
    - chronisch-obstruktive Atemwegserkrankungen
    4. Überempfindlichkeit gegen einen der Bestandteile von Clonid-Ophtal® 1/8% AT oder Tim-Ophtal® 0,5% AT
    5. Nicht erlaubte Vor- oder Begleittherapie (siehe unten)
    6. Frauen im gebärfähigen Alter ohne adäquate Kontrazeption
    7. Schwangerschaft (bestehende oder geplante) und Stillzeit
    8. Aktuelle maligne Erkrankung
    9. Schwere organische, neurologische und/oder psychiatrische Erkrankung
    10. Patienten, die der Weitergabe ihrer pseudonymisierten Daten im Rahmen der Dokumentations- und Mitteilungspflichten nicht zustimmen
    11. Teilnahme an einer anderen klinischen Prüfung (parallel oder innerhalb der letzten 6 Monate)
    12. Erneute Teilnahme an dieser Prüfung
    13. Bekannter Alkohol-, Drogen- und/oder Medikamentenmissbrauch
    14. Patienten, die nicht in der Lage sind, Umfang und Tragweite der Prüfung zu verstehen bzw. als unzuverlässig (non-compliant) bezüglich der Anwendung der Augentropfen/des Studienprocederes anzusehen sind
    15. Geplanter Umzug oder Urlaub während des Studienverlaufs, so dass nicht alle Visiten eingehalten werden können
    16. Unzureichendes Sprachverständnis (Deutsch in Wort und Schrift)
    E.5 End points
    E.5.1Primary end point(s)
    Für die Verträglichkeitsanalyse werden alle in dieser Studie erhobenen „unerwünschten Ereignisse (UE)“ herangezogen. Hierbei werden Nebenwirkungen (NW) getrennt von denjenigen UE ausgewertet, die vom Prüfarzt nicht als Nebenwirkungen klassifiziert wurden.

    .Anmerkung: Eine NW im Gegensatz zu einem UE ist dadurch gekennzeichnet, dass ein „möglicher“, „wahrscheinlicher“ oder „gesicherter“ Zusammenhang zwischen der aufgetretenen NW und dem angewendeten Prüfpräparat vom Prüfarzt gesehen wird.

    Die Auswertung des Nebenwirkungsprofils von Clonid-Ophtal® 1/8% und Tim-Ophtal® 0,5% erfolgt in hierarchischer Form.
    Die Beschreibung des Nebenwirkungsprofils erfolgt wesentlich durch die Berechnung von unterschiedlichen Nebenwirkungsraten. Diese beschreiben das Verhältnis zwischen der Anzahl von Patienten mit der untersuchten Nebenwirkung (oder Nebenwirkungsklasse) und der Anzahl aller Patienten, die dem Risiko einer Nebenwirkung in dem zugrunde gelegten Zeitraum ausgesetzt sind.
    Unterschiede in den berechneten Nebenwirkungsraten zwischen den Behandlungs-gruppen werden durch Differenzbildung und den zugehörigen 95% Konfidenz-intervallen beschrieben.
    Sollten die berechneten Konfidenzintervalle auf einen signifikanten Unterschied hinweisen (z.B. 95% Konfidenzintervall der Differenzen schließt die „0“ nicht ein), ist dieses Ergebnis mit besonderer Aufmerksamkeit dahingehend zu beurteilen, ob diese Signifikanz auch von medizinischer Relevanz ist oder nicht.
    Zunächst wird die globale Nebenwirkungsrate berechnet. In einem 2. Schritt wird nach systemischen und lokalen Nebenwirkungen getrennt analysiert. Die systemischen und lokalen Nebenwirkungen werden dann zusätzlich in subjektive und objektive Nebenwirkungen unterteilt.
    Unerwünschte Ereignisse ohne oder mit unwahrscheinlichem Zusammenhang zum Prüf- bzw. Vergleichspräparat werden getrennt von den Nebenwirkungen analysiert.
    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 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) 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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months6
    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 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 2005-06-06. 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 state180
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 180
    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)
    2-wöchige therapiefreis Nachbeobachtungsphase
    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 Decision2005-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-10
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