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    The EU Clinical Trials Register currently displays   43692   clinical trials with a EudraCT protocol, of which   7246   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2010-021188-34
    Sponsor's Protocol Code Number:LT2380-PIII-05/10
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-021188-34
    A.3Full title of the trial
    Efficacy and safety assessment of intracameral T2380 (Fixed combination of lidocaine, phenylephrine and tropicamide) for mydriasis and anaesthesia in phacoemulsification cataract surgery
    Valutazione della efficacia midiatrica e anestetica e della tolleranza di una soluzione iniettabile per via intracamerulare di T2380 (associazione fissa di lidocaina, fenilefrina e tropicamide) nella chirurgia della cataratta per facoemulsificazione.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy, safety and anaesthetic effect of esolution administered during cataract surgery.
    Valutazione dell'effetto di dilatazione sulla pupilla, dell'efficacia anestetica e della tolleranza di una soluzione somministrata nel bulbo oculare durante l'intervento chirurgico di cataratta per facoemulsificazione.
    A.4.1Sponsor's protocol code numberLT2380-PIII-05/10
    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 SponsorLABORATORIES THEA
    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 THEA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPHIDEA MARVIN S.R.L.
    B.5.2Functional name of contact pointCristina Lumini - Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressVia C. Colombo, 1
    B.5.3.2Town/ cityCorsico
    B.5.3.3Post code20094
    B.5.4Telephone number+ 390245053519
    B.5.5Fax number+ 390245053505
    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 nameT2380
    D.3.2Product code T2380
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 73-78-9
    D.3.9.2Current sponsor codeT2380
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB02921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 61-76-7
    D.3.9.2Current sponsor codeT2380
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB03777MIG
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.31
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTROPICAMIDE
    D.3.9.1CAS number 1508-75-4
    D.3.9.2Current sponsor codeT2380
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB11342MIG
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.02
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typesoluzione locale con effetto anestetico e midriatrico
    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
    subjects with cataract
    Pazienti affetti da cataratta
    E.1.1.1Medical condition in easily understood language
    subjects affected by cataract phatology
    soggetti affetti da cataratta
    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 SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    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
    The primary aim of this study is to evaluate mydriasis of T2380 versus topical reference treatments during cataract surgery.
    L’obiettivo principale di questo studio sarà valutare la dilatazione pupillare (midriasi) ottenuta con il T2380, confrontandola a quella ottenuta con trattamenti topici nel gruppo di controllo durante l’intervento della cataratta.
    E.2.2Secondary objectives of the trial
    Pupil size measured at the time T4;Pupil size measured at the times;Assessment of patient’s discomfort at T1 to T5;Time necessary for obtaining sufficient mydriasis; Questioning about the number of supplementary drops or injection necessary to maintain mydriasis;Questioning about the number of supplementary drops or injection necessary to maintain anaesthesia; Delay between the first instillation and the first incision; Delay between T3 and cefuroxime injection; Total surgical time;Assessment of the surgeon statisfaction of each stage
    Misurazione della dimensione della pupilla nel tempo T4;Misurazione della dimensione della pupilla nel tempo;Valutazione del disagio del paziente da T1 a T5;Tempo necessario per l’ottenimento di una midriasi sufficiente;Numero di gocce o volume di iniezioni aggiuntive necessarie per mantenere la midriasi;Numero di gocce o volume di iniezioni aggiuntive necessarie per mantenere l’anestesia;Intervallo tra la prima instillazione e la prima incisione;Intervallo tra T3 e l’iniezione di Cefurossima;Durata totale dell’intervento chirurgico;Valutazione della soddisfazione del chirurgo durante le fasi seguenti: 2a incisione, capsuloressi, facoemulsificazione, aspirazione della corteccia, inserimento dell’impianto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed and dated informed consent;Male or female aged from 40 to 88 years old; Scheduled to undergo unilateral cataract surgery (Under topical anesthesia and using clear corneal self sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector); Pupil diameter ≥ 7 mm at selection visit [after the following dilatation protocol: 1 tropicamide 0.5% + 1 drop phenylephrine 10%; with a maximum of 3 combined instillations with interval of 10 mn, i.e. T 0mn, + T 10mn and + T 20mn if necessary]
    Consenso informato datato e firmato;Uomo o donna, di età compresa tra 40 e 88 anni;Chirurgia unilaterale della cataratta programmata (In anestesia locale, incisione in cornea chiara autosigillante-facoemulsificazione-con lente intraoculare morbida e iniettore);Diametro della pupilla dilatata ≥ 7 mm durante la visita di selezione [In base alla procedura di dilatazione seguente: 1 goccia di tropicamide 0,5% + 1 goccia di fenilefrina 10%; procedura ripetuta 3 volte al massimo con un intervallo di 10 min].
    E.4Principal exclusion criteria
    Ophthalmic non-inclusion criteria  Surgical conditions in the eye to be operated: - Combined surgery - Previous intraocular surgery  Non-surgical conditions in the eye to be operated: - Iatrogenic or traumatic or congenital cataract. - Pupillary abnormalities (irregular,..) - Very dark iris - Iris synechiae - Eye movement disorder (Nystagmus,..) - Dacryocystitis and all others pathologies of tears drainage system - History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis,…) - Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) - History of ocular traumatism, infection or inflammation within the last 3 months - Pseudoexfoliation, exfoliative syndrome,  Ophthalmic conditions in the contra lateral eye: - Best corrected visual acuity < 1/10 - Patient already included in the study for phakoexeresis - History of ophthalmic surgical complication (cystoid macular oedema,..)  Presence of glaucoma and/or ocular hypertension history in either eye Systemic/non ophthalmic non-inclusion criteria None of the following criteria  General history: - Diabetes not controlled - Insulin-dependent diabetes - Surdity - Excessive anxiety - Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled arterial hypertension etc...) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study  Allergic history: - Known hypersensitivity to one of the components of the study medications or to test products - Allergic rhinitis Specific non-inclusion criteria for women - Pregnancy, lactation - Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR - Women not hysterectomised, menopaused or surgically sterilized Non-inclusion criteria related to general conditions - Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent - Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) - Participation in another clinical study - Already included once in this study - Ward of court - Patient not covered by the Social Security scheme (For France)
     Condizioni chirurgiche nell’occhio da operare: - Chirurgia combinata; - Antecedente di chirurgia intraoculare.  Condizioni non-chirurgiche nell’occhio da operare: - Cataratta iatrogena, traumatica o congenita; - Anomalia della pupilla (irregolarità…); - Iride molto scura; - Sinechia dell’iride; - Movimento involontario dell’occhio (Nistagmo…); - Dacriocistite e altra patologia legata al sistema di drenaggio delle lacrime; - Antecedenti di patologia infiammatoria oculare (irite, uveite, cheratite erpetica); - Patologia corneale, epiteliale, stromale o endoteliale, residua o evolutiva (incluse ulcera corneale e cheratiti puntate superficiali); - Antecedente di trauma oculare, infezione o infiammazione negli ultimi 3 mesi; - Sindrome da esfoliazione o pseudo esfoliazione.  Condizioni oftalmologiche nell’occhio controlaterale: - Acuità visiva corretta &lt; 1/10; - Paziente già incluso nello studio per una faco-exeresi; - Antecedente di complicanza chirurgica (specificatamente edema maculare cistoide,...).  Glaucoma e/o antecedente di ipertensione oculare in uno dei due occhi. Criteri di esclusione di ordine sistemico (non oftalmologico):  Antecedenti di ordine generale: - Diabete non controllato; - Diabete insulino-dipendente; - Sordità; - Ansia eccessiva; - Qualsiasi antecedente medico o chirurgico, disordine o malattia quale una malattia metabolica acuta o cronica grave: epatica, endocrina, neoplasica, ematologica, malattia psichiatrica grave, patologia cardiovascolare non controllata… (quale ad esempio: angor instabile, ipertensione non controllata, ecc) e/o qualsiasi fattore aggravante o anomalia strutturale, giudicata dal ricercatore incompatibile con lo studio.  Antecedente di allergia: - Ipersensibilità nota a uno dei componenti dei prodotti dello studio o prodotti utilizzati nel presente studio; - Rinite allergica. Criteri di esclusione specifici per le donne: - Gravidanza o allattamento; - Donna in età fertile che non utilizzi metodi contraccettivi sicuri (contraccettivi orali, spirale o contraccezione mediante impianto sottocutaneo) oppure che non sia stata sottoposta a sterilizzazione chirurgica o che non sia in menopausa. Criteri di esclusione legati alle condizioni generali: - Paziente incapace di comprendere le istruzioni dello studio e pertanto di fornire il proprio consenso informato; - Paziente non osservante (ad esempio non disposto a presentarsi alle visite di controllo, stile di vita che interferisce con l’osservanza); - Paziente che partecipa ad altro studio clinico; - Paziente già incluso nel presente studio; - Maggiore sotto tutela; - Soggetto non iscritto al regime di previdenza sociale (per la Francia).
    E.5 End points
    E.5.1Primary end point(s)
    Midriasys evaluation activities
    Valutazione dell'attività midriatrica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximun 1 month after surgery
    massimo 1 mese dopo l'intervento chirurgico
    E.5.2Secondary end point(s)
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 No
    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. 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 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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    LPLV december 2012
    LPLV dicembre 2012
    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 months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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.1.1Number 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 492
    F.4.2.2In the whole clinical trial 492
    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 patient follow up after the end of the study is planned
    Non è previsto nessun trattamento e/o assistenza dopo il termine dello studio
    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 Decision2011-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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