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    Summary
    EudraCT Number:2010-023216-14
    Sponsor's Protocol Code Number:HP-AM2-001
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-19
    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 ConcernedEstonia - SAM
    A.2EudraCT number2010-023216-14
    A.3Full title of the trial
    A Phase II, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study of 10 Weeks Treatment with Fluoxetine 20 mg and Computer Software-Based Training in Adult Patients with Amblyopia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combination treatment of antidepressant medication with eye training program to treat lazy eye in adults
    A.3.2Name or abbreviated title of the trial where available
    Fluoxetine Lazy Eye Study
    A.4.1Sponsor's protocol code numberHP-AM2-001
    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 SponsorHermo Pharma Ltd
    B.1.3.4CountryFinland
    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 supportHermo Pharma Ltd.
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHermo Pharma Ltd.
    B.5.2Functional name of contact pointClinical Development information
    B.5.3 Address:
    B.5.3.1Street AddressViikinkaari 4
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post codeFI-00790
    B.5.3.4CountryFinland
    B.5.4Telephone number+358401585669
    B.5.5Fax number+358102962286
    B.5.6E-mailinfo@hermopharma.com
    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 Seronil 20 mg hard capsule
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUOXETINE HYDROCHLORIDE
    D.3.9.1CAS number 59333-67-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.4
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    treatment of adult amblyopia - amblyopia due to myopic or hyperopic anisometropia, or, congenital esotropia
    E.1.1.1Medical condition in easily understood language
    Lazy eye
    Laisa silma sündroom
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10065008
    E.1.2Term Amblyopia unilateral
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10001906
    E.1.2Term Amblyopia
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10042158
    E.1.2Term Strabismic amblyopia
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10015475
    E.1.2Term Esotropia
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the improvement in visual acuity in the amblyopic eye as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart after 10 weeks of medication (fluoxetine 20 mg) and computer software-based training combined with occlusion of the dominant eye. A clinically significant improvement is defined as a negative change of 0.2 logarithm of the minimum angle of resolution (logMAR) units (i.e. 10 characters on the ETDRS chart).
    E.2.2Secondary objectives of the trial
    • change in visual acuity 3 months after treatment
    • stability of the change in visual acuity during follow-up
    • relative change in visual acuity after 10 weeks of treatment
    • relative change in visual acuity 3 months after treatment
    • relative change in visual acuity after 10 weeks of treatment between both eyes
    • relative change in visual acuity 3 months after treatment between both eyes
    • change in contrast sensitivity in the amblyopic eye after 10 weeks of treatment
    • change in contrast sensitivity 3 months after treatment
    • stability of change in contrast sensitivity during follow-up
    • change in binocularity after 10 weeks of treatment
    • change in binocularity 3 months after treatment
    • stability of change in binocularity during follow-up
    • change in near vision and crowding after 10 weeks of treatment
    • change in near vision and crowding 3 months after treatment
    • stability of change in near vision and crowding during follow-up
    • safety of fluoxetine
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub-study performed in Finland only: NeuroImaging of adult patients with anisometropic amblyopia during Phase II double blind multicenter study.
    Protocol HP-AM2-002, dated 20 June 2011, version 03-00 Final.

    Objectives: To evaluate the changes in cortical neuronal activity recorded by neuroimaging with magneto- and encephalography (M/EEG) after 10 weeks of treatment with fluoxetine, eye-shading and computer-based cognitive training in the main study (HP-AM2-001)
    E.3Principal inclusion criteria
    1. Provide written informed consent, i.e. they must be willing and able to comply with the study procedures.
    2. Male or female, aged 18-60 years (inclusive).
    3. Diagnosed with amblyopia due to myopic or hyperopic anisometropia, or, congenital esotropia.
    4. Visual acuity in the amblyopic eye ≥0.30 and <1.10 logMAR (at least one character on the ETDRS chart).
    5. Visual acuity in the dominant eye ≤0.10 logMAR.
    6. Anisometropia ≤4.25 diopters.
    7. Judged to be otherwise healthy by the Investigator, based on medical history, brief physical examination, eye examination and clinical laboratory assessments. Patients with abnormal clinical laboratory values or who have other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study.
    8. Females of childbearing potential are eligible for the study provided (i) they have a negative urine pregnancy test at the screening visit and (ii) they agree to use adequate contraception (e.g. oral, depot or implanted hormonal contraception, intrauterine device, surgical sterilization or partner vasectomy) from the screening visit until at least 4 weeks after the last dose of study medication (Week 16).
    E.4Principal exclusion criteria
    1. Diagnosed with other reasons for strabismus as the primary reason for amblyopia.
    2. History of any amblyopia therapy in the 2 years before the screening visit.
    3. Any eye surgery less than 6 months before the screening visit.
    4. Observed off-fixation by ophthalmological examination (extra-foveal fixation)
    5. Other ophthalmological pathologies that may affect the patient’s rehabilitation.
    6. Pregnant, planning to become pregnant during the study, or breast feeding.
    7. History of depressive illness or treatment with antidepressant medication within 6 months before the screening visit.
    8. Use of psychiatric medication within 6 months before the screening visit.
    9. Receipt of an experimental treatment for any disease within 4 weeks before the screening visit.
    10. History or presence of illicit drug use or alcohol abuse.
    11. History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the patient at unacceptable risk or that could prevent the patient from completing the study.
    12. Hypersensitivity to fluoxetine or any of its excipients.
    13. Epilepsy or a history of seizures.
    14. History of mania or hypomania.
    15. Concomitant treatment with any of the following medications that are known to interact with fluoxetine:
    a. Monoamine oxidase inhibitor (MAOI) - less than 2 weeks after discontinuation of an irreversible MAOI, or, less than one day after discontinuation of a reversible MAOI-A.
    b. Phenytoin.
    c. Serotonergic drugs.
    d. Lithium or tryptophan.
    e. Drugs predominantly metabolized by CYP2D6 isoenzyme, e.g. flecainide, encainide, carbamazepine and tricyclic antidepressants.
    f. Oral anticoagulants.
    g. St John’s Wort (Hypericum perforatum).
    h. Benzodiazepines.
    i. Tamoxifen
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline (Week 0) to end of treatment (Week 10) in visual acuity in the amblyopic eye as measured by ETDRS chart.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline (week 0) to end of treatment (10 weeks).
    E.5.2Secondary end point(s)
    • Change from baseline (Week 0) to end of follow-up (Week 22) in visual acuity in the amblyopic eye as measured by ETDRS chart.
    • Change from end of treatment (Week 10) to end of follow-up (Week 22) in visual acuity in the amblyopic eye as measured by ETDRS chart.
    • Relative change (%) in visual acuity in the amblyopic eye from baseline (Week 0) to end of treatment (Week 10) as measured by ETDRS chart.
    • Relative change (%) in visual acuity in the amblyopic eye from baseline (Week 0) to end of follow-up (Week 22) as measured by ETDRS chart.
    • Difference between the dominant and amblyopic eye in relative change (%) in visual acuity from baseline (Week 0) to end of treatment (Week 10) as measured by ETDRS chart.
    • Difference between the dominant and amblyopic eye in relative change (%) in visual acuity from baseline (Week 0) to end of follow-up (Week 22) as measured by ETDRS chart.
    • Change from baseline (Week 0) to end of treatment (Week 10) in contrast sensitivity in the amblyopic eye as measured by Pelli Robson chart.
    • Change from baseline (Week 0) to end of follow-up (Week 22) in contrast sensitivity in the amblyopic eye as measured by Pelli-Robson chart.
    • Change from end of treatment (Week 10) to end of follow-up (Week 22) in contrast sensitivity in the ablyopic eye as measured by Pelli-Robson chart.
    • Change from baseline (Week 0) to end of treatment (Week 10) in binocularity as measured by Bagolini striated glass test.
    • Change from baseline (Week 0) to end of follow-up (Week 22) in binocularity as measured by Bagolini striated glass test.
    • Change from end of treatment (Week 10) to end of follow-up (Week 22) in binocularity as measured by Bagolini striated glass test.
    • Change from baseline (Week 0) to end of treatment (Week 10) in near vision and crowding as measured by Landolt C ring charts.
    • Change from baseline (Week 0) to end of follow-up (Week 22) in near vision and crowding as measured by Landolt C ring charts.
    • Change from end of treatment (Week 10) to end of follow-up (Week 22) in near vision and crowding as measured by Landolt C ring charts.

    Safety Endpoints:
    • Changes from baseline (Week 0) to end of treatment (Week 10), end of weaning-off and washout (Week 14) and end of follow-up (Week 22) in adverse events (AEs), physical examination, vital signs and laboratory safety tests (Week 0, 10, 14).
    • Changes in ophthalmological examinations from baseline (Week 0) to end of follow-up (Week 22).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline (week 0) to end of treatment (week 10).
    Change from baseline (week 0) to end of follow-up (week 22).
    Change from end of treatment (week 10) to end of follow-up (week 22).
    Change in safety parameters from baseline (week 0), to end of treatment (week 10), end of wean-off (week 14) and end of follow-up (week 22).
    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 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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    End of the trial is when the last patient has completed visit 7 - follow-up, week 22 after randomisation.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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: 34
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 34
    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)
    No further treatment plans after the subject has ended the 3-month follow-up period of the trial.
    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 Decision2012-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-23
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