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    Summary
    EudraCT Number:2015-005405-36
    Sponsor's Protocol Code Number:LT1580-301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-005405-36
    A.3Full title of the trial
    Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease Treatment
    Valutazione dell'efficacia e della sicurezza di T1580 versus un veicolo nel trattamento della sindrome dell'occhio secco
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease Treatment
    Valutazione dell'efficacia e della sicurezza di T1580 versus un veicolo nel trattamento della sindrome dell'occhio secco
    A.3.2Name or abbreviated title of the trial where available
    LT1580-301
    LT1580-301
    A.4.1Sponsor's protocol code numberLT1580-301
    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 SponsorLABORATOIRES THEA
    B.1.3.4CountryFrance
    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 supportLaboratoires Théa
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratoires Théa
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street Address12 Rue Louis Blériot
    B.5.3.2Town/ cityClermont-Ferrand, Cedex 2
    B.5.3.3Post code63017
    B.5.3.4CountryFrance
    B.5.4Telephone number0033473981436
    B.5.5Fax number0033473981436
    B.5.6E-mails.guyon@theapharma.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 nameCiclosporin
    D.3.2Product code [T1580]
    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 INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor codeT1580
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    Dry Eye Disease
    Sindrome dell'occhio secco
    E.1.1.1Medical condition in easily understood language
    Dry eye disease
    Sindrome dell'occhio secco
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10013778
    E.1.2Term Dry eyes
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10013777
    E.1.2Term Dry eye syndrome
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of T1580 versus vehicle in moderate to severe keratitis caused by Dry Eye Disease (DED)
    Valutare l'efficacia di T1580 versus un veicolo nel trattamento della cheratite di grado da moderato a grave causata dalla sindrome dell'occhio secco (DED)
    E.2.2Secondary objectives of the trial
    To evaluate the safety of T1580
    Valutare la sicurezza di T1580
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Ancillary study : sampling of conjunctiva cells for the measurement of HLA-DR and blood sample for pharmacokinetics.
    These samplings will be performed in a subset of patients in selected sites in order to obtain some interpretable blood samples and some conjunctival cytology impression samples.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Studio ancillare: prelievo di cellule della congiuntiva per la misurazione di HLA-DR e di campioni di sangue per la farmacocinetica.
    Questi campionamenti verranno effettuati in un sottogruppo di pazienti in siti selezionati al fine di ottenere alcuni campioni di sangue valutabili e campioni delle cellule congiuntivali per citologia ad impressione.
    E.3Principal inclusion criteria
    1.1. Informed consent signed and dated by Screening visit.
    1.2. Menopausal woman.
    1.3. Final menstrual period at least 3 years before the Screening visit.
    1.4. Patient with BILATERAL persistent DED having required continuous tear substitute for the last 2 years at Screening visit.
    1.5. Patient with at least ONE eye with:
    a. Schirmer test without anaesthesia scored = 2 mm/5 min, and < 10 mm/5 min at Screening visit,
    AND
    b. Keratitis with a count of corneal dots stained by fluorescein > 32 dots AND corresponding to a grade 3 or a grade 4 on the Oxford scale at Baseline visit (please, refer to Oxford scale).
    1.6. Patient with Ocular Surface Disease Index (OSDI) = 23 (i.e., at least moderate symptomatology of DED) at Baseline visit.
    1.7. Patient having completed the patient daily diary on ocular symptoms during period # 2 of run-in at Baseline visit (only one day with missing data is permitted).
    1.8. Patient not having instilled any drop at least 6 hours prior to corneal fluorescein staining (CFS) assessment at Baseline visit.
    1.1. Consenso informato firmato e datato entro la visita di screening.
    1.2. Donne in menopausa.
    1.3. Ultima mestruazione almeno 3 anni prima della visita di screening.
    1.4. Pazienti con sindrome dell'occhio secco BILATERALE persistente che richiede la somministrazione continuativa di lacrime artificiali per almeno i 2 anni precedenti la visita di screening.
    1.5. Pazienti che presentano almeno UN occhio con:
    a. Test di Schirmer senza anestesia con punteggio = 2 mm/5 min e < 10 mm/5 min alla visita di screening,
    E
    b. Cheratite con una conta di punti corneali colorati con fluoresceina > 32 punti E corrispondente ad un grado 3 o 4 sulla Scala di Oxford alla visita basale (si prega di fare riferimento alla Scala di Oxford).
    1.6. Pazienti con un indice di infiammazione della superficie oculare (OSDI) 23 (ad esempio, una sintomatologia di grado almeno moderato della sindrome dell'occhio secco) alla visita basale.
    1.7. Pazienti che hanno completato il diario giornaliero per la paziente sui sintomi oculari durante il periodo n. 2 del periodo di preparazione alla visita basale (è permesso solamente un giorno con dati mancanti).
    1.8. Pazienti che non hanno instillato alcuna goccia per almeno 6 ore prima del test di colorazione corneale (CFS) alla visita basale.
    E.4Principal exclusion criteria
    Presence of an active condition :
    a. Ocular rosacea, uveitis,
    b. Abnormal eye lid anatomy, blinking, or naso-lachrymal drainage system,
    c. Ocular hypertension or glaucoma requiring an ophthalmic medicinal product,
    d. Infectious conjunctivitis, severe blepharitis, and/or progressive pterygium.
    Major corneal hypoaesthesia value = 20 mm as measured with a Cochet-Bonnet aesthesiometer.
    Far best corrected visual acuity (BCVA) worse than or equal to + 0.7 LogMar.
    Any history of, or active, relevant ocular disorder condition other than those listed above which is likely to interfere with the study results as judged by the investigator at Screening or Baseline visits. Any ophthalmic disease likely to change the assessment of fluctuating blurred vision linked to dry eye disease or may result in a visual acuity deterioration in the following year.
    Other exclusion criteria are defined in the protocol (Exclusion criteria regarding ocular history, Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions).
    Presenza di una malattia attiva:
    a. Rosacea oculare, uveite,
    b. Anomalie dell'anatomia della palpebra o del sistema di drenaggio naso-lacrimale, blinking oculare,
    c. Ipertensione oculare o glaucoma che richiede un prodotto medicinale oftalmico,
    d. Congiuntivite infettiva, blefarite grave e/o pterigio progressivo.
    Ipoestesia corneale maggiore = 20 mm misurata mediante estesiometro Cochet-Bonnet.
    Migliore acuità visiva corretta (BCVA) peggiore o uguale a + 0,7 LogMar.
    Qualsiasi storia di patologie oculari attive rilevanti diverse da quelle elencate sopra, che possono interferire con i risultati dello studio in base al giudizio dello sperimentatore alla visita di screening o alla visita basale. Qualsiasi patologia oftalmica che possa alterare la valutazione della visione offuscata e fluttuante associata alla sindrome dell'occhio secco o che possa provocare un deterioramento dell'acuità visiva nel corso dell'anno successivo.
    Altri criteri di esclusione sono definiti nel protocollo (Criteri di esclusione relativi alla storia medica oculare, Criteri di esclusione sistemici/non oftalmici, Criteri specifici di esclusione per donne in età fertile, Criteri di esclusione legati alle condizioni generali).
    E.5 End points
    E.5.1Primary end point(s)
    The change from Baseline in Corneal Fluorescein Staining (CFS)
    I cambiamenti osservati dalla visita basale in base all'esame di colorazione corneale con fluoresceina (CFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    assessed at Month 6
    eseguito il Mese 6
    E.5.2Secondary end point(s)
    CFS response to treatment; Combined CFS and OSDI response to treatment.
    La risposta CFS al trattamento; La risposta combinata al trattamento valutata in termini di CFS e di punteggio OSDI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    assessed at Month 6; assessed at Month 6
    eseguito il Mese 6; eseguito il Mese 6
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Primo periodo di 6 mesi in doppio cieco seguito da un periodo di 6 mesi in aperto
    The first 6-month period will be double-masked followed by an open-label 6-month treatment period
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Armenia
    Bosnia and Herzegovina
    Georgia
    Russian Federation
    Serbia
    Ukraine
    Austria
    Belgium
    Bulgaria
    Croatia
    Estonia
    Hungary
    Italy
    Latvia
    Lithuania
    Poland
    Romania
    United Kingdom
    Czechia
    Greece
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 295
    F.4.2.2In the whole clinical trial 450
    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
    nessuno
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-01-08
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