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    Summary
    EudraCT Number:2012-004605-27
    Sponsor's Protocol Code Number:Occhuiosecco
    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:2012-10-25
    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 number2012-004605-27
    A.3Full title of the trial
    Study Prospective Randomized Controlled Double-Blind: Comparison of tear substitute (Siccafluid) and Autologous Serum in Dry Eye Disease
    Studio Prospettico Randomizzato Controllato in Doppio Cieco: Confronto tra sostituto lacrimale (Siccafluid) e Siero Autologo nella Patologia dell’Occhio Secco
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study that will compare a tear substitute (Siccafluid) with autologous serum (from the blood of the subject) in the pathology of dry eye, according to a plan that neither the doctor nor the patient will know which treatment the patient is assigned.
    Studio che intende confrontare un sostituto lacrimale (Siccafluid) con il siero autologo (proveniente dal sangue del soggetto) nella patologia della secchezza oculare, secondo un disegno che nè il medico, nè il paziente sapranno a quale trattamento il paziente stesso verrà sottoposto.
    A.3.2Name or abbreviated title of the trial where available
    Siccafluid and autologous serum
    Siccafluid e Siero autologo
    A.4.1Sponsor's protocol code numberOcchuiosecco
    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 SponsorAZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
    B.1.3.4CountryItaly
    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 supportTHEA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Arcispedale S. Maria Nuova
    B.5.2Functional name of contact pointS.C. di Oculistica
    B.5.3 Address:
    B.5.3.1Street AddressViale Risorgimento, 80
    B.5.3.2Town/ cityReggio Emilia
    B.5.3.3Post code42123
    B.5.3.4CountryItaly
    B.5.4Telephone number0522 295397
    B.5.6E-mailmarchi.sylvia@asmn.re.it
    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 SICCAFLUID*GEL OFT 10G 2,5MG/G
    D.2.1.1.2Name of the Marketing Authorisation holderTHEA FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Eye gel
    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 INNBelzalconio cloruro, sorbitolo, lisina monoidrata, sodio acetato triidrato, polivinile alcool
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dry eye disease
    Patologia dell'occhio secco
    E.1.1.1Medical condition in easily understood language
    Dry eye disease
    Patologia 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018728
    E.1.2Term Gritty eyes
    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
    Assess which of the two treatments results in a greater improvement in objective signs of dry eye in a month (improvement of at least 2 degrees of the scale of Oxford).
    Valutare quale tra le due terapie determina un maggiore miglioramento dei segni oggettivi di secchezza oculare a un mese (miglioramento di almeno 2 gradi della scala di Oxford).
    E.2.2Secondary objectives of the trial
    Assess which of the two treatments results in a greater improvement in subjective signs of dry eye in a month.
    Assessing whether there is a difference in response to therapy based on the severity of symptoms at baseline and between the two groups (group artificial tears and autologous serum) that within the same treatment group.
    Assessing whether there is a difference in response to therapy according to the different pathological condition that determines the dry eye is between the two groups (the group artificial tears and autologous serum) that within the same group of therapy.
    Determine the efficacy and safety of topical treatment with autologous serum in dry eye disease.
    Valutare quale tra le due terapie determina un maggiore miglioramento dei segni soggettivi di secchezza oculare a un mese.
    Valutare se esiste una differenza di risposta alla terapia in base alla gravità dei sintomi alla baseline sia tra i due gruppi (il gruppo lacrime artificiali e siero autologo) che all’interno dello stesso gruppo di terapia.
    Valutare se esiste una differenza di risposta alla terapia in base alla diversa condizione patologica che determina la secchezza oculare sia tra i due gruppi (il gruppo lacrime artificiali e siero autologo) che all’interno dello stesso gruppo di terapia.
    Determinare l’efficacia e la sicurezza del trattamento topico con siero autologo nella malattia dell’occhio secco.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 - Presence of altered cornea (punctate keratopathy) and / or conjunctival least grade I ° according to the classification scheme of Oxford (Annex A) after staining with fluorescein to the cornea and conjunctiva with lissamine green for.

    2 - Tear break-up time fluorescein <10 sec (established cut-off for the diagnosis of dry eye by Lemp and Hamill in 1973)

    3 - Presence of dry eye caused by:

    • by reduction of tear production (Aqueous Deficient Dry Eye ADDE) and comprises:
    • dry eye associated with Sjogren's syndrome
    • Primary: presence of ADDE in combination with the symptoms of dry mouth, presence of autoantibodies, evidence of reduced salivary secretion and score positive on biopsy of a minor salivary gland.
    • Secondary: combines the features of primary SS with features of autoimmune connective tissue disease a clear (RA, systemic lupus erythematosus, polyarteritis nodosa, Wegener's granulomatosis, systemic sclerosis, primary biliary sclerosis)
    • dry eye not associated with Sjögren's syndrome:
    • for primary and secondary deficiencies of the lacrimal gland
    1- Presenza di alterazione corneale (cheratopatia puntata) e/o congiuntivale almeno di grado I° secondo la classificazione dello Schema Oxford (Allegato A) dopo colorazione con fluoresceina per la cornea e con verde lissamina per la congiuntiva.

    2- Tear break-up time fluoresceina &lt; 10 sec (cut-off stabilito per la diagnosi di occhio secco da Lemp e Hamill nel 1973)

    3- Presenza di occhio secco causato da:

    • da riduzione della produzione lacrimale (Aqueous Deficient Dry Eye ADDE) e comprende:
    • occhio secco associato a sindrome di Sjogren
    • primaria: presenza di ADDE in combinazione con i sintomi della bocca secca, presenza di autoanticorpi, evidenza di una ridotta secrezione salivare e score positivo alla biopsia di una ghiandola salivare minore.
    • Secondaria: combina le caratteristiche della SS primaria con le caratteristiche di una chiara malattia connettivale autoimmune (AR, lupus eritematoso sistemico, poliarterite nodosa, granulomatosi di Wegener, sclerosi sistemica, sclerosi biliare primaria)
    • occhio secco non associato a sindrome di Sjogren:
    • per insufficienze primarie e secondarie delle ghiandole lacrimali
    E.4Principal exclusion criteria
    a. duct obstruction of the lacrimal gland
    b. causes of increased tear evaporation causes intrinsic
    c. Systemic use of drugs that could affect the tear film, tear secretion or the surface area of ​​the eye (eg pilocarpine).
    d. The use of previous or concurrent topical medications that may affect the evaluation of the drug's
    and. History of previous ocular surgery, including refractive surgery, eyelid surgery or corneal surgery.
    f. extrinsic causes (disorders of the ocular surfaces, use of contact lenses, allergic conjunctivitis)
    g. Contraindications to the use of autologous serum: Hemoglobinopathies with high levels of bilirubin, viral and fungal infections bacterial active; Paraproteinemie; postivi Serology tests (HIV, HCV, HBV).
    h. Age <18 years
    a. ostruzione dei dotti delle ghiandole lacrimali
    b. cause da aumentata evaporazione lacrimale per cause intrinseche
    c. Uso sistemico di farmaci che potrebbero influenzare il film lacrimale, la secrezione lacrimale o la superificie oculare (es pilocarpina).
    d. L’uso di farmaci topici precedenti o concomitanti che potrebbero alterare la valutazione dell’effetto del farmaco
    e. Storia di precedente chirurgica oculare, tra cui la chirurgia refrattiva, la chirurgia palpebrale o la chirurgia corneale.
    f. cause estrinseche (disordini della superfici oculare, uso di lenti a contatto, congiuntiviti allergiche)
    g. Controindicazioni all’uso di siero autologo: Emoglobinopatie con elevati livelli di bilirubina; Infezioni batteriche virali e fungine attive; Paraproteinemie; Esami sierologici postivi ( HIV, HCV, HBV).
    h. Età &lt; 18 anni
    E.5 End points
    E.5.1Primary end point(s)
    improvement of at least 2 degrees of the scale of Oxford
    miglioramento di almeno 2 gradi della scala di Oxford
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    1 mese
    E.5.2Secondary end point(s)
    improvement of at least 2 degrees of the scale of Oxford for both treatments
    miglioramento di almeno 2 gradi della scala di Oxford per i due trattamenti
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month
    1 mese
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Siero autologo
    Autologous Serum
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-10-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state100
    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)
    At the end of the study, after the opening of the blind, it is decided to treat the patient.
    Al fine dello studio, dopo l'apertura del cieco, si decide il trattamento per il paziente.
    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 Decision2012-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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