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    Summary
    EudraCT Number:2016-001091-30
    Sponsor's Protocol Code Number:FG-PRE-101
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-14
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2016-001091-30
    A.3Full title of the trial
    A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Repeated Administration, Crossover Study to Establish Safety, Tolerability, and Efficacy of PresbiDrops in Presbyopic Subjects
    Dvojno slepa, randomizirana, s placebom nadzorovana, navzkrižna študija faze 2a s ponovno administracijo za oceno varnosti, prenašanja in učinkovitosti zdravila Presbidrops pri osebah s starovidnostjo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a double-blind, randomized, vehicle controlled, two-way crossover repeated administration study performed in presbyopic subjects.
    To je dvojno slepa, randomizirana, s placebom nadzorovana, navzkrižna študija s ponavljajočo aplikacijo zdravila v preskušanju, ki se izvaja pri preiskovancih s starovidnostjo (starostno daljnovidnost).
    A.4.1Sponsor's protocol code numberFG-PRE-101
    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 SponsorORASIS Pharmaceuticals Ltd
    B.1.3.4CountryIsrael
    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 supportORASIS Pharmaceuticals Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationORASIS Pharmaceuticals Ltd
    B.5.2Functional name of contact pointElad Kedar, CEO
    B.5.3 Address:
    B.5.3.1Street Address89 Medinat Hayehudim St.
    B.5.3.2Town/ cityHerzliya
    B.5.3.4CountryIsrael
    B.5.6E-mailelad.kedar@orasis-pharma.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 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 namePresbiDrops
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.11 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
    Presbyopia is part of the natural ageing process of the eye. It is usually noticed at around the age of 40 years. The main symptom of this condition is a progressive blurring of vision when performing near tasks such as reading, sewing, working at a computer, using a tablet mobile phone etc. The individual may complain of headaches and become more reliant on better illumination when attempting to see fine detail close up.
    Starovidnost je del naravnega procesa staranja oči. Običajno se starovidnost opazi okoli starosti 40 let. Glavni simptom tega stanja je napredujoča zamegljenost vida pri bližinskih opravilih, npr. pri branju, šivanju, delu z računalnikom, uporabi tabličnega računalnika, mobilnega telefona itd. Pri tem oseba trpi zaradi glavobolov in lahko postane bolj odvisna od močnejše svetlobe, ko želi videti drobne podrobnosti.
    E.1.1.1Medical condition in easily understood language
    The natural ageing process of the eye
    Naravni proces staranja oči
    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
    Primary
    To establish safety and tolerability of repeated administration of PresbiDrops in presbyopic subjects
    Primarni cilji
    ocenitev varnosti in prenašanja zdravila v preskušanju PresbiDrops ob večkratni oz. ponavljajoči aplikaciji pri osebah s starovidnostjo
    E.2.2Secondary objectives of the trial
    Secondary
    To determine the efficacy of repeated administration of PresbiDrops in presbyopic subjects
    Sekundarni cilj
    določitev učinkovitosti zdravila v preskušanju PresbiDrops ob večkratni oz. ponavljajoči aplikaciji pri osebah s starovidnostjo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women between 40 and 65 years of age (inclusive)
    Subjects who provide written informed consent to participate in the study
    Subjects have signs of presbyopia upon ophthalmic examination
    Subjects have normal presbyopia with low distance refraction (sphere no greater than ±0.75 Dioptres cylinder no greater than ± 0.75DC, refraction along any principal meridian no greater than 1.00 Dioptres)
    Subjects must have best corrected vision of 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is > +1.00 Dioptres
    Subjects in general good health in the opinion of the Investigator as determined by medical history
    Women with childbearing potential must have a negative urine pregnancy test at Screening and be willing and able to use a medically acceptable method of birth control or postmenopausal.
    Acceptable methods of birth control in this study include: vasectomy, tubal ligation, consistent use of an approved oral contraceptive (birth control pill), intrauterine device (IUD), hormonal implants, contraceptive injection or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam).
    Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
    Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study
    Moški in ženske med 40 in do vključno 65 let
    Preiskovanci, ki bodo podpisali Obrazec privolitev po poučitvi
    Preiskovanci imajo znake presbiopije na očesnem pregledu
    Preiskovanci imajo normalno presbiopijo z nizko refraktivno napako na daljavo (sfera ne sme biti večja od ± 0,75D, cilinder ne sme biti večji od ± 0.75D, refrakcija v katerikoli glavni meridiani ne sme biti večja od 1,00 D)
    Preiskovanci morajo imeti najbolje korigirano vidno ostrino obojestransko 20/20 in uporabljajo očala za blizu ali bifokalna očala z addicijo, večjo od +1.00 dioptrije
    Preiskovanci so po mnenju raziskovalca dobrega zdravja glede na anamnezo
    Ženske v rodni dobi morajo imeti ob pregledu negativen urinski test nosečnosti in morajo biti pripravljene in sposobne uporabljati medicinsko sprejemljivo metodo kontracepcije. Lahko so tudi v obdobju po menopavzi. Sprejemljive metode kontracepcije v tem preskušanju so: vazektomija, ligacija jajcevodov, dosledna uporaba odobrenega peroralnega kontraceptiva (tablete za nadzorovanje rojstev), intrauterinski vstavki (IUV), hormonski kontraceptivi, injekcije kontraceptivov ali metoda dvojne bariere (diafragma s spermicidnim gelom ali kondom s kontracepcijsko peno). Za ženske, ki so v obdobju po menopavzi se smatra, da nimajo več menstruacije 12 zaporednih mesecev pred podpisom Obrazca privolitev po poučitvi.
    Preiskovanci morajo biti sposobni razumeti zahteve preskušanja in jim morajo biti pripravljeni slediti
    E.4Principal exclusion criteria
    History of macular disease or any other ocular conditions or congenital malformation
    Any medical condition known to affect the structure of uvea, cornea, lens or retina or main function of the eyes
    No cataract or minimal nuclear sclerosis
    Severe dry eye
    Any topical ophthalmic medications, other than artificial tears (up to a maximum of 4 times per day) and medications that are associated with fluctuation of accommodative capacity and/or pupil size, unless on a stable dose for at least 3 months before the Screening visit
    Contact lenses for the past three months before the Screening visit
    A difference of more than 0.50 Dioptres between the manifest spherical equivalent and the wavefront refraction spherical equivalent Pupil size less than 2,5 mm in either eye prior to dilation at ambient light of 8-15 lux prior to the Baseline visit
    A history of herpes (of any kind) in either eye
    Cataract surgery and/or refractive surgery in either eye
    Known contraindication, hypersensitivity and/or allergy to any study drugs or excipients
    Any acute illness (e.g. acute infection) within 48 hours of first study drug administration, which is considered of significance by the Investigator
    Participation in another clinical trial with drugs received within 30 days of Screening
    Pregnant or currently lactating women
    Zgodovina makularne bolezni ali drugih očesnih boleznih ali prirojene malformacije
    Vsako zdravstveno stanje za katerega je znano, da vpliva na strukturo uvee, roženice, leče, očesne mrežnice ali na glavne funkcije oči
    Prisotnost katarakte ali minimalne jedrne skleroze
    Zelo suhe oči
    Uporaba topikalnih oftalmoloških zdravil, razen umetnih solz (do največ 4-krat na dan) in zdravil, ki so povezane z nihanjem akomodacijskih zmogljivosti in / ali velikost zenice, razen če ne gre za nespremenjen odmerek vsaj 3 mesece pred obdobjem obiskom presejanja
    Uporaba kontaktnih leč v zadnjih treh mesecih pred obiskom presejanja
    Razlika več kot 0.50 dioptrije med manifestnih sfernim ekvivalentom in sfernim ekvivalentom wavefront refrakcije.
    Velikost zenice manj kot 2,5 mm v obeh očesih pred širjenjem pod vplimo zunanje svetlobe v jakosti od 8 do 15 luxov pred izhodiščnim obiskom
    Anamneza herpesa (vseh vrst) v katerekoli očesu
    Operacija katarakte in / ali operacija za izboljšanje refrakcije očesa v kateremkoli očesu
    Znane kontraindikacije, preobčutljivosti in / ali alergija na katerokoli zdravilo v preskušanju ali na pomožne snovi
    Vsaka akutna bolezen (na primer akutna okužba) v roku 48 ur od prve aplikacije zdravila v preskušanju, ki se šteje za pomembno po mnenju raziskovalca
    Sodelovanje v drugem kliničnem preskušanju z zdravili prejetimi znotraj 30 dni do obsika namenjenega za presejanje
    Noseče ali trenutno doječe matere
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    At least a 2 lines improvement from Baseline in uncorrected intermediate and near visual acuity (monocular and binocular)
    Primarni cilj preskušanja z vidika učinkovitosti:
    izboljšanje za vsaj 2 vrstici v primerjavi z izhodiščem od pri nekorigirani vmesni in bližnji ostrini vida (na enem in obeh očesih)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The maximum treatment duration is 28 days (14 days drug, 14 days placebo)
    Zdravljenje lahko traja največ 28 dni (14 dni zdravilo, 14 dni placebo)
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoint:
    Change from Baseline of the depth of focus at distance and near
    Change from Baseline in uncorrected distance visual acuity (monocular and binocular)
    Change from Baseline in spectacle independency (reported by the subjects in structured study questionnaire)
    Change from Baseline in pupil diameter and appearance
    Change from Baseline of stability of tear film
    Change from Baseline of visual field test results
    Change from Baseline of the ocular 3rd 4th and 5th higher order aberrations (spherical aberration, trefoil and coma)
    Sekundarna cilji preskušanja z vidika učinkovitosti:
    sprememba globine fokusa pri gledanju na daleč in blizu glede na izhodiščno stanje
    sprememba nekorigirane distalne vidne ostrine glede na izhodiščno stanje (na enem in obeh očesih)
    sprememba v neodvisnosti vida glede na izhodiščno stanje (ki so jih poročali preiskovanci v strukturiranem študijskem vprašalniku)
    sprememba premera in videza zenice glede na izhodiščno stanje
    sprememba stabilnosti solznega filma glede na izhodišče
    sprememba rezultatov vidnega polja glede na izhodišče
    sprememba očesne aberacije 3., 4. in 5. višjega reda (sferične aberacije, trifoliarne in koma) glede na izhodišče
    E.5.2.1Timepoint(s) of evaluation of this end point
    64 days (~9 weeks)
    64 dni (~ 9 tednov)
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Prenašanje
    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 Yes
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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: 40
    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 No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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)
    All subjects will be followed up for two weeks after end of the Treatment period. Study procedures will be done on Day 45± 3 days (Visit 5) as specified in the Schedule of Assessments.
    Vsi preiskovanci bodo spremljani dva tedna po koncu obdobja zdravljenja. Postopki preskušanja bodo opravljeni na dan 45 ± 3 dni (obisk 5), kot je določeno v seznamu razporeditve preiskav.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-25
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