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    Summary
    EudraCT Number:2017-004108-23
    Sponsor's Protocol Code Number:17097AB-AS
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-08-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-004108-23
    A.3Full title of the trial
    Low-dose atropine eye drops to reduce progression of myopia in children: a multi-centre placebo controlled randomised trial in the United Kingdom (CHAMP UK)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Low-dose atropine eye drops for children with myopia in the United Kingdom
    A.3.2Name or abbreviated title of the trial where available
    Low-dose atropine eye drops for children with myopia in the UK
    A.4.1Sponsor's protocol code number17097AB-AS
    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 SponsorBelfast Health and Social Care Trust
    B.1.3.4CountryUnited Kingdom
    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 organisationQueen's University Belfast
    B.5.2Functional name of contact pointProf Augusto Azuara-Blanco
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Public Health, Institute of Clinical Sciences - Block A, Grosvenor Road
    B.5.3.2Town/ cityBelfast
    B.5.3.3Post codeBT12 6BA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02890976460
    B.5.5Fax number02890632699
    B.5.6E-maila.azuara-blanco@qub.ac.uk
    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 name0.01% atropine
    D.3.4Pharmaceutical form Eye drops, solution
    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 INNAtropine
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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, 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
    Myopia
    E.1.1.1Medical condition in easily understood language
    Short-sightedness
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    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
    The primary objective is to evaluate the efficacy of low dose (0.01%) atropine eye drops to slow the progression of short-sightedness in UK children after 24 months of treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To evaluate the safety and tolerability of low dose atropine eye drops
    • To determine how the atropine eye drops work to slow the progression of short-sightedness in children

    The exploratory objective is to explore the influence of other factors in the progression of short-sightedness, including hours of outdoor activity, use of spectacles for correction of vision, iris colour, ethnicity, and family history.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In order to assess the effects on recruitment of local media (radio) advertisement, we will conduct a Study Within A Trial (SWAT) three and six months after commencing recruitment. We will compare the effects on recruitment using two interventions: local radio advertisement (for two weeks) 3 months after starting recruitment in two randomly chosen sites; and local radio advertisement (for two weeks) 6 months after starting recruitment in two randomly chosen sites. The primary outcome will be the change in recruitment after the radio advertisement compared to before the advertisement. Secondary outcomes will be retention of participants in the trial, and changes in the number of potentially eligible participants who are assessed or approached for the trial.

    A SWAT to explore study drug adherence by comparing a non-expensive and pragmatic method of adherence assessment i.e. bottle weighing, with the electronic adherence monitoring data captured from a Medical Events Monitoring System (MEMS). At one site (Belfast), eye drop bottles will be weighed on calibrated scales in the pharmacy department at the time of dispensing and again on return to pharmacy at the end of the six-month treatment period.

    A novel recruitment method will be investigated through embedding the TRECA (TRials Engagement in Children and Adolescents) study within the CHAMP UK trial. TRECA is investigating whether providing children and young people with information about a trial through a multimedia information (MMI)resources impacts on recruitment and retention rates as well as the quality of decision-making about trial participation. TRECA is funded by the NIHR (HS&DR 14/21/21), with ethical and HRA approval already obtained. The MMIs are websites with text, images, animations and videos about the CHAMP UK trial. Phase one of TRECA saw the development of the MMIs, through participatory design and usability testing with children and adolescents with long-term health conditions, their parents and clinicians. The MMIs will be based on information from the CHAMP UK PIS. The MMIs also include generic animations that cover elements about trials, including:
    • what is a trial?
    • why do we do trials?
    • who is in a research team
    • assent and consent
    In addition, the CHAMP UK MMIs will have an explainer animation about the study on the front/home page of the MMI. The idea is that this explainer covers the main features of the trial in approximately 60 seconds of animation. Individuals approached to participate in CHAMP UK will be randomly allocated to receive either:
    • the standard PIS, or
    • the CHAMP UK MMI, developed by TRECA in conjunction with the CHAMP UK study team, or
    • both the MMI and PIS
    E.3Principal inclusion criteria
    1. Age 6-12 years (at the time of consenting)
    2. Myopia of -0.5D or greater (spherical equivalent refractive error) in both eyes
    3. Best-corrected distance visual acuity (BCDVA) of 0.20 logMAR or better in both eyes
    E.4Principal exclusion criteria
    1. Children with other ocular morbidities
    2. Myopia of -10D or greater in either eye
    3. Astigmatism of 2D or higher in either eye
    4. Amblyopia
    5. Significant health problems that can compromise the ability to attend research visits or complete the trial
    6. Other factors that may compromise the ability to attend the research appointments
    7. Parents or children with poor understanding of the English language
    8. Children enrolled in other interventional trials
    9. Allergy or hypersensitivity to atropine or excipients
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is spherical equivalent refractive error (SER) (i.e. myopia severity) of both eyes after 24 months measured by autorefractor under cycloplegia, adjusted for baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants will attend a total of five research visits; the first will be the baseline visit. Participants will then attend a research visit every six months for the duration of the study.

    -Baseline
    -Month 6
    -Month 12
    -Month 18
    -Month 24
    E.5.2Secondary end point(s)
    Secondary Outcomes
    - Central axial length: measured using a laser biometer at central fixation conditions
    - Best corrected distance visual acuity (BCdVA) (uniocular and binocular): assessed using the logMAR ETDRS chart. This is a standard letter chart used in research to ensure accuracy and validity of the acuity measurements and has been shown to be repeatable in children (Manny 2003)
    - Near visual acuity (uniocular and binocular): tested using near logMAR ETDRS at 40 cm
    - Reading speed: measured with the Wilkins Rate of Reading test
    - Pupil diameter: measured using an autorefractor
    - Accommodation: measured prior to the instillation of cycloplegia using the autorefractor. The measures will be taken monocularly in each eye and binocularly (minimum 3 measurements per condition). The accommodation response (accommodation lag) will be determined by calculating the difference between the Accommodation Response (AR = near MSE (autorefractor)) and the Accommodation Stimulus
    - Spectacle correction
    - Tolerability: using a 4-point scale to quantify, from the point of view of the participant, (1) local irritation/stinging associated with eye drop instillation; (2) photophobia; and (3) difficulties reading and writing
    - Adverse event rates and allergic reactions rates.
    - Quality of Life: measured using the EQ-5D-Y

    Exploratory Outcomes/Mechanistic Evaluations
    - Peripheral axial length: measured using a laser biometer at peripheral fixation conditions
    - Peripheral retinal defocus: measured with the autorefractor at central and peripheral fixation conditions
    - Anterior chamber depth: measured with a laser biometer
    - Iris colour: measured using a visual grading scale of dark brown, light brown, blue, green, grey
    - Height and weight to provide information about the links between the child’s development and eye growth and potentially information about lifestyle
    - Hours of outdoor activity: measured using an activities questionnaire
    - Ciliary body biometry: measured using anterior-segment OCT (AS-OCT). This will enable changes in lens position and ciliary muscle changes resulting from atropine use to be compared with normal myopic growthChorio-retinal thickness: measured using spectral domain OCT (SR-OCT). This will enable differences in choroidal thickness resulting from atropine use to be compared with normal myopic growth
    E.5.2.1Timepoint(s) of evaluation of this end point
    Central axial length–Baseline, Months 6, 12, 18 & 24
    BCdVA–Baseline, Months 6, 12, 18 & 24
    Near visual acuity–Baseline, Months 6, 12, 18 & 24
    Reading speed–Baseline, Months 6, 12, 18 & 24
    Pupil diameter–Baseline, Months 6, 12, 18 & 24
    Accommodation–Baseline, Months 6, 12, 18 & 24
    Spectacle correction–Baseline, Months 6, 12, 18 & 24
    Tolerability–Months 6, 12, 18 & 24
    Adverse event rates–Months 6, 12, 18 & 24
    Quality of Life–Baseline, Months 6, 12, 18 & 24
    Peripheral axial length–Baseline, Months 12 & 24
    Peripheral retinal defocus–Baseline, Months 12 & 24
    Anterior chamber depth–Baseline, Months 6, 12, 18 & 24
    Iris colour–Baseline
    Height & weight– Baseline, Months 6, 12, 18 & 24
    Hours of outdoor activity–Baseline, Months 6, 12, 18 & 24
    Ciliary body biometry–Baseline, months 1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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 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 concerned4
    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
    For the purposes of submitting the end of trial notification to the Sponsor and the Research Ethics Committee (REC), the end of trial will be considered to be when the database lock occurs for the final analysis. The trial will be stopped prematurely if:
    • Mandated by the REC
    • Mandated by the Sponsor (e.g. following recommendations from the TSC
    • Funding for the trial ceases
    This is to ensure that all data has been cleaned, quality controlled and monitored prior to analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days31
    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: 289
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 247
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 42
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 6-12 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state289
    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)
    As atropine sulphate 0.01% is not licenced for use in the UK, administration of study eye drops will stop after 24 months of trial participation. Management of the participant’s myopia at the end of the trial will be in accordance with normal clinical practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Northern Ireland Clinical Trials Unit
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-02
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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