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    Summary
    EudraCT Number:2010-021410-34
    Sponsor's Protocol Code Number:EOC-2-Opht-2010
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-24
    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 number2010-021410-34
    A.3Full title of the trial
    A double blind randomized study on the efficacy of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in children
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of cycloplegics
    A.4.1Sponsor's protocol code numberEOC-2-Opht-2010
    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 SponsorMedical Centre Haaglanden
    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 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 Yes
    D.2.1.1.1Trade name cyclopentolaat hydrochloride 1% 10mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderChauvin-Bausch&Lomb, Benelux NV, Brussels, Belgium
    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.3.1Product namecyclopentolate hydrochloride 1%; 10 mg/ml
    D.3.2Product code RVG 09359
    D.3.4Pharmaceutical form Eye drops*
    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.3.9.3Other descriptive namecyclopentolate hydrochloride
    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.3.11 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 No
    D.3.11.8Extractive medicinal product No
    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 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 1%; 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderChauvin-Bausch&Lomb; Benelux NV, Brussels, Belgium
    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.3.1Product nametropicamide 1%; 10 mg/ml
    D.3.2Product code RVG 10167
    D.3.4Pharmaceutical form Eye drops*
    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.3.9.3Other descriptive nametropicamide
    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.3.11 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 No
    D.3.11.8Extractive medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Depth of cycloplegia; changes of astigmatism; recuperation from cycloplegia and mydriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10011719
    E.1.2Term Cycloplegia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10011719
    E.1.2Term Cycloplegia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare one dose of the short acting tropicamide combined with one dose of the longer acting cyclopentolate (c+t) with a double dose of the longer acting cyclopentolate (c+c)

    Primary outcomes
    •Detection of statistical or clinical significant- or no difference in depth of cycloplegia; e.g. residual accommodation, between c+c and c+t.

    •Detection of statistical or clinical significant- or no difference in recuperation time of 1) ciliary paralysis and 2) sphincter paralysis between c+c and c+t.
    E.2.2Secondary objectives of the trial
    •Detection of statistical or clinical significant- or no difference in time of stability of maximum cycloplegia between c+c and c+t.

    •Detection of statistical or clinical significant- or no difference in 1) depth of cycloplegia 2)in time to maximum cycloplegia 3) in time of stability of maximum cycloplegia between eye-colour main groups in c+c and c+t.

    •Identification of factors that affect 1) depth of cycloplegia 2) time of stability of maximum cycloplegia 3) recuperation time from ciliary and sphincter paralysis in c+c and c+t.

    •Detection of statistical or clinical significant or no differences in changes in astigmatism during the time course of cycloplegia in c+c and c+t.
    •Establishment of a statistical significant or no relationship between incomplete cycloplegia and changes in astigmatism in c+c and c+t.
    •Detection of statistical or clinical significant- or no differences in astigmatism between relaxed and demanding accommodation circumstances in c+c and c+t.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    This investigator initiated study is designed as a prospective, single-centre, cross sectional, quantitative, randomized double blind trial with repeated measurements.

    The study is divided in three parts. Part I measures residual accommodation; e.g. depth of cycloplegia and stability of (complete) cycloplegia in time. Part II measures (monitors) recuperation of ciliary paralysis in time and part III measures (monitors) recuperation of spincter paralysis in time.
    E.3Principal inclusion criteria
    Patient is considered for the study when:
    • Good general health
    • Age 7 to 13 years
    o Group 4 - 8 of the Dutch primairy school system
    Part I and II
    • Hypermetropia; e.g. > 0. 50 diopters in spherical equivalence (SEQ) values*
    • Good accommodation; e.q. > 10 diopters with dynamic retinoscopy
    • Sufficient reading capabilities
    • Best corrected distance visual acuity (BCDVA) of > 0.7 in each eye
    • Best corrected near visual acuity (BCNVA) of > 1.0 in each eye
    Part III
    • Emmetropia or myopia in SEQ values
    • Isocoria and normal pupillary responses


    * SEQ= sphere + cylinder:2
    E.4Principal exclusion criteria
    • Not healthy
    • Aged <6 and >13 year
    • Attending group 3 of the Dutch school system
    • Attending secondary school
    Part I and II
    • Refractive errors < +0.50
    • Best corrected visual acuity of < 0.7 in one or both eye’s
    • Insufficient reading capabilities
    • Insufficient accommodation
    Part III
    • Emmetropia or hypermetropia
    • An-isocoria or abnormal pupillary responses
    E.5 End points
    E.5.1Primary end point(s)
    Part I
    Primary outcome parameter is residual accommodation; e.g. depth of cycloplegia. Secondary outcome parameter are time of stability of (maximum) cycloplegia and changes in astigmatism. Differences will be considered statistical significant if p<0.05. A difference in residual accommodation of > 0.50 D, a time difference in stability of > 10 minutes, and a change of > 0.50 D cylinder or a change of >5° cylinder ax will be considered clinical significant.

    Part II
    Primary outcome parameter is time to recuperation of ciliary paralyses. Differences will be considered statistical significant if p<0.05. A difference in recuperation time of > 2 hours will be considered clinical significant.

    Part III
    Primary outcome parameter is time to recuperation of sphincter paralyses. Differences will be considered statistical significant if p<0.05. A difference in recuperation time of > 2 hours will be considered clinical significant.
    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 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) 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 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 No
    E.8.2.3Other No
    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 Information not present in EudraCT
    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 the study is defined as the moment that the last subject completed the measurements of part I and the last subject completed the questionnaires of part II and the last subject completed the questionnaires of part III, these data are admitted in the SPSS database and the database is closed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    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 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 state423
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 423
    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 Decision2010-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
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