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    Summary
    EudraCT Number:2012-005219-18
    Sponsor's Protocol Code Number:MICRO1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005219-18
    A.3Full title of the trial
    The influence of dropsize of tropicamide 0.5% eyedrops on pupildilation
    De invloed van de druppelgrootte van tropicamide 0,5% oogdruppels op de mate van pupilverwijding
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The influence of dropsize of tropicamide eyedrops on pupildilation
    De invloed van de druppelgrootte van tropicamide oogdruppels op de mate van pupilverwijding
    A.3.2Name or abbreviated title of the trial where available
    MICRO1
    A.4.1Sponsor's protocol code numberMICRO1
    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 SponsorSt. Elisabeth Ziekenhuis
    B.1.3.4CountryNetherlands
    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 supportSt. Elisabeth Ziekenhuis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Elisabeth Ziekenhuis
    B.5.2Functional name of contact pointSecretariaat Ziekenhuisapotheek
    B.5.3 Address:
    B.5.3.1Street AddressHilvarenbeekseweg 60
    B.5.3.2Town/ cityTilburg
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031135625
    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 Tropicamide
    D.2.1.1.2Name of the Marketing Authorisation holderThea Pharma
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNtropicamide
    D.3.9.3Other descriptive nameTROPICAMIDE
    D.3.9.4EV Substance CodeSUB11342MIG
    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) 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 Tropicamide
    D.2.1.1.2Name of the Marketing Authorisation holderThea Pharma
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNtropicamide
    D.3.9.3Other descriptive nameTROPICAMIDE
    D.3.9.4EV Substance CodeSUB11342MIG
    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) 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
    Pupil diagnostics
    Pupil diagnostiek
    E.1.1.1Medical condition in easily understood language
    Pupil diagnostics
    Pupil diagnostiek
    E.1.1.2Therapeutic area Not possible to specify
    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
    Is the degree of pupildilation, achieved after administrating a 4.5 microliter microdrop tropicamide 0.5% equivalent to the pupildilation after a regular 30 microliter eydrop tropicamide 0.5% in healthy volunteers?

    Is de mate van pupilverwijding na toediening van een microdruppel tropicamide 0,5% met een volume van 4,5 microliter vergelijkbaar met de pupilverwijding na een normale druppel tropicamide 0,5% met een volume van 30 microliter bij gezonde vrijwilligers?
    E.2.2Secondary objectives of the trial
    Is there a subjective difference in the degree of physical discomfort, experienced after administration of a microdrop compared to a regular eyedrop?
    Qualitative evaluation of the mydriatic reponse/time curves of both the microdrop and the regular eyedrop.
    Geeft een tropicamide 0,5% oogdruppel met een volume van 4,5 microliter minder fysieke klachten (onder andere prikkeling bij druppelen, droge mond, hoofdpijn) dan een tropicamide 0,5% oogdruppel met een volume van 30 microliter?
    Hoe verhoud de mydriatische respons/tijd-curve van een microdruppel tropicamide zich tot die van de standaarddruppel?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age between18-64 years
    informed consent
    leeftijd tussen 18-64 jaar
    geïnformeerde toestemming
    E.4Principal exclusion criteria
    eye disease, risk factors for angle-closure glaucoma, previous eyetrauma/surgery, dioptric value >+6, cardiac disease, diabetes, medication for the eye, medication influencing pupildiameter, substance abuse, (possible) pregnancy, breastfeeding
    Personen met een oogaandoening, personen met een nauwe kamerhoek, personen met een hoge oogboldruk, personen die ooit oogtrauma hebben gehad of geopereerd zijn aan een oog, verziende personen met een sterkte >+6, personen met een cardiale aandoening of een verhoogd risico daarop, personen met diabetes, personen die oogmedicamenten gebruiken, personen die medicamenten gebruiken die van invloed zijn op of pupildiameter, personen die drugs gebruiken, zwangere vrouwen, vrouwen met een zwangerschapswens, vrouwen die borstvoeding geven.
    E.5 End points
    E.5.1Primary end point(s)
    Within-subject pupildilation (compared to baseline) of a regular eyedrop and a microdrop at t=40 min.
    Maximale pupildiametertoename (ten opzichte van baseline) van de standaard druppel en de microdruppel per proefpersoon op tijdstip t=40 min
    E.5.1.1Timepoint(s) of evaluation of this end point
    40 minutes after eyedrop administration
    40 minuten na toediening oogdruppel
    E.5.2Secondary end point(s)
    Physical discomfort, experienced after administration of a microdrop and a regular eyedrop.
    Qualitative evaluation of the mydriatic reponse/time curves of both the microdrop and the regular eyedrop.
    -Fysieke klachten (prikkeling, droge mond, hoofdpijn) na toediening van een microdruppel en van een standaard druppel
    -Verloop van de pupildiameter in de tijd. ( mydriatische respons/tijd-curves van de microdruppel en de standaarddruppel)
    E.5.2.1Timepoint(s) of evaluation of this end point
    following both studysessions
    na de beide meetsessies
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    de onderzoeker is geblindeerd, de proefpersonen niet
    the investigator is blinded, the subjects are not
    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 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 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 years
    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 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: 28
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state28
    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
    geen
    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 Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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