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    Summary
    EudraCT Number:2019-001660-30
    Sponsor's Protocol Code Number:CHL.3/01-2019/M
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-001660-30
    A.3Full title of the trial
    A prospective, observer-masked, randomized clinical trial to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anesthetics in phacoemulsification.
    Estudio clínico aleatorizado, prospectivo y con enmascaramiento para el observador para investigar y comparar la eficacia clínica de cloroprocaína gel al 3 % y tetracaína colirio al 0,5 % como anestésicos tópicos para la facoemulsificación.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, observer-masked, randomized clinical trial to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anesthetics in phacoemulsification.
    Estudio clínico aleatorizado, prospectivo y con enmascaramiento para el observador para investigar y comparar la eficacia clínica de cloroprocaína gel al 3 % y tetracaína colirio al 0,5 % como anestésicos tópicos para la facoemulsificación.
    A.4.1Sponsor's protocol code numberCHL.3/01-2019/M
    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 SponsorSintetica S.A.
    B.1.3.4CountrySwitzerland
    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 supportSintetica S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIris Pharma
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressLes Nertières, Allée Hector Pintus
    B.5.3.2Town/ cityLa Gaude
    B.5.3.3Post code06610
    B.5.3.4CountryFrance
    B.5.4Telephone number+33493594959
    B.5.5Fax number+33493594960
    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 nameChloroprocaine 3%
    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 INNCHLOROPROCAINE
    D.3.9.1CAS number 133-16-4
    D.3.9.4EV Substance CodeSUB06193MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Tetracaine 0.5 %
    D.2.1.1.2Name of the Marketing Authorisation holderBausch Health Ireland Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 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 INNTETRACAINE
    D.3.9.1CAS number 94-24-6
    D.3.9.4EV Substance CodeSUB10940MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    cataract surgery
    cirugía de cataratas
    E.1.1.1Medical condition in easily understood language
    cataract surgery
    cirugía de cataratas
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    Equivalence evaluation of Test versus Reference products in terms of proportion of subjects with a successful surface anesthesia for cataract surgery, without any supplementation at T4 (just before Intra Ocular Lens implantation)

    Successful surface anesthesia & Supplementation are defined in the study protocol.
    Evaluación de la equivalencia del producto en investigación frente al producto de referencia, en términos de la proporción de pacientes con una anestesia superficial satisfactoria para la cirugía de cataratas, sin suplementación (véanse las definiciones a continuación) en el punto T4 (justo antes de la implantación de la lente intraocular)

    Anestesia superficial satisfactoria y Suplementación viene definidas en el protocolo del estudio.
    E.2.2Secondary objectives of the trial
    Assess the clinical efficacy and safety of 3% chloroprocaine gel compared to those of tetracaine 0.5% eye drop.
    Evaluación de la eficacia clínica y seguridad de cloroprocaína gel al 3 % frente a tetracaína colirio al 0,5 %
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be enrolled in this study, subjects must fulfil all these inclusion criteria:
    1. Signed and dated informed consent
    2. Male or female aged ≥ 18 years
    3. Senile or pre-senile cataract
    4. Scheduled to undergo cataract surgery in a single eye at a time (clear corneal self-sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector)
    Para poder ser incluidos en este estudio, los sujetos deben cumplir todos los siguientes criterios de inclusión:
    1. Consentimiento informado firmado y fechado
    2. Hombre o mujer ≥18 años de edad
    3. Catarata senil o presenil
    4. Tener programada una cirugía de cataratas, en un solo ojo a la vez (incisiones autosellantes corneales claras, facoemulsificación, cirugía de lente intraocular plegable con inyector)
    E.4Principal exclusion criteria
    Patients fulfilling at the selection visit ONE OR MORE of the following exclusion criteria will not be enrolled in the study:
    Ophthalmic exclusion criteria
     Surgical conditions in the eye to be operated:
    1. Combined surgery
    2. Previous intraocular surgery
    3. Previous corneal refractive surgeries less than 6 months before screening
     Non-surgical conditions in the eye to be operated:
    4. Non Senile or non pre-senile cataract (e.g.: traumatic, pathological or congenital cataract)
    5. Pupillary abnormalities (irregular, etc.)
    6. Iris synechiae
    7. Eye movement disorder (nystagmus, etc.)
    8. Dacryocystitis and all other pathologies of tears drainage system
    9. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
    10. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
    11. History of ocular traumatism, infection or inflammation within the last 3 months
    12. Pseudo-exfoliation, exfoliative syndrome
    13. Prior intravitreal injections within 7 days of the surgery
     Ophthalmic conditions in the contra-lateral eye:
    14. Best corrected visual acuity < 1/10
    15. Patient already included in the study for phakoexeresis
    16. History of ophthalmic surgical complication (cystoid macular oedema, etc.)

    Other criteria are defined in the study protocol (Systemic/non ophthalmic exclusion criteria, Specific exclusion criteria for women, Exclusion criteria related to general conditions, Exclusion criteria related to previous and concomitant medications / non-product therapies).
    En el estudio no se incluirá a los pacientes que respondieron durante la visita de selección a UNO O MÁS de los siguientes criterios de exclusión:
    Criterios oftálmicos de exclusión
    Afecciones quirúrgicas en el ojo que se va a operar:
    1. Cirugía combinada
    2. Cirugía intraocular previa
    3. Cirugías refractivas de córnea previas, menos de 6 meses antes de la selección
    Afecciones no quirúrgicas en el ojo que se va a operar:
    4. Catarata no senil o no presenil (p. ej.: catarata traumática, patológica o congénita)
    5. Anomalías pupilares (irregularidad, etc.)
    6. Sinequia del iris
    7. Trastorno del movimiento ocular (nistagmo, etc.)
    8. Dacrocistitis y todas las demás patologías del sistema de drenaje de lágrimas
    9. Antecedentes de enfermedad ocular inflamatoria (iritis, uveítis, queratitis herpética)
    10. Enfermedad corneal, epitelial, estromal o endotelial, residual o evolutiva (incluida la úlcera corneal y la queratitis punteada superficial)
    11. Antecedentes de traumatismo, infección o inflamación oculares en los últimos 3 meses
    12. Seudoexfoliación, síndrome exfoliativo
    13. Inyecciones intravítreas durante los 7 días anteriores a la cirugía
    Trastornos oftálmicos en el ojo contralateral:
    14. Mejor agudeza visual corregida <1/10
    15. Paciente ya incluido en el estudio para facoexéresis
    16. Antecedentes de complicación quirúrgica oftálmica (edema macular cistoide,
    etc.)

    En el protocolo del estudio se definen otros criterios (Criterios de exclusión de carácter sistémico/no oftálmico, Criterios de exclusión específicos para las mujeres , Criterios de exclusión relativos a factores de carácter general, Criterios de exclusión relacionados con los tratamientos previos y concomitantes/tratamientos no farmacológicos).
    E.5 End points
    E.5.1Primary end point(s)
    Τhe proportion of subjects in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4.
    La proporción de pacientes de cada grupo de tratamiento con una anestesia superficial
    satisfactoria, sin ninguna suplementación en el punto cronológico T4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T4 = just before Intra Ocular Lens implantation
    T4 = usto antes de la implantación de la lente intraocular.
    E.5.2Secondary end point(s)
    Efficacy end-points during surgery:
     Successful surface anesthesia at T1, T2 and T3 based on patient questioning: Patient’s operated eye discomfort.
     Time to obtain sufficient anesthesia (use of forceps).
     Total time of anesthesia
     Blinking reflex dropping a water drop at the end of the surgery
     Number of supplemental drops necessary for obtaining and/or maintaining anesthesia
     Supplementary treatments (general anesthesia or intra-operative systemic analgesia) necessary for obtaining and/or maintaining anesthesia
     Total surgical time
     Assessment of surgical comfort by the surgeon of each stage of the surgical procedure.
     Assessment of the global efficacy by the surgeon for anesthesia.

    Safety end-points:
    - Ocular symptoms (pain, irritation/burning/stinging, photophobia, foreign body sensation) will be graded by the patients according to the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
    - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells) assessed by slit lamp examination, flare, and other objective ocular signs will be graded according to the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
    Modification of the basal status of the following assessments:
    - Slit lamp examination and fluorescein test
    - Endothelial cell counts (specular microscopy)
    - Corneal thickness (pachymetry)
    - Best far corrected visual acuity
    - Fundoscopy
    - Intra-ocular pressure
    - Vital signs (blood pressure and heart rate)
    - AEs occurrence
    - Surgeon satisfaction: “How do you consider the study product global tolerance” will be graded according to the following scale: 0 = very satisfactory, 1 = satisfactory, 2 = not very satisfactory, 3 = unsatisfactory.
    - Patient global satisfaction at Visit 3/D2 (5-scale points questionaire read by a masked observer).
    Variables de eficacia durante la cirugía:
    - Anestesia superficial satisfactoria en los puntos T1, T2 y T3 de acuerdo con las preguntas al paciente sobre: Molestia del paciente en el ojo operado.
    - Tiempo transcurrido hasta que se obtiene una anestesia suficiente (uso de pinzas).
    - Tiempo total de anestesia
    - Reflejo de parpadeo al echar una gota de agua al final de la cirugía
    - Número de gotas suplementarias necesarias para obtener y/o mantener la anestesia
    - Tratamientos suplementarios (anestesia general o analgesia sistémica intraoperatoria) necesarios para obtener y/o mantener la anestesia
    - Duración total de la intervención
    - Evaluación de la comodidad para el cirujano en cada fase del procedimiento quirúrgico
    - Evaluación por parte del cirujano de la eficacia global de la anestesia

    Variables de seguridad:
    - Los síntomas oculares (dolor, irritación/ardor/escozor, fotofobia, sensación de cuerpo extraño) serán clasificados por los pacientes de acuerdo con la siguiente escala: 0 = ausente, 1 = leve, 2 = moderado, 3 = grave.
    - Síntomas oculares objetivos (edema palpebral, quemosis, hiperemia conjuntival, secreción conjuntival, conjuntivitis fólico-papilar, puntuaciones de tinción corneal, células de la cámara anterior) evaluados mediante exploración con lámpara de hendidura, brote y otros signos oculares objetivos de acuerdo con la siguiente escala: 0 = ninguno, 1 = leve, 2 = moderado, 3 = grave.
    Modificación del estado inicial de las siguientes evaluaciones:
    - Exploración con lámpara de hendidura y prueba de tinción con fluoresceína
    - Recuentos de células endoteliales (microscopia especular)
    - Espesor corneal (paquimetría)
    - Mejor agudeza visual corregida de lejos
    - Oftalmoscopia
    - Tensión intraocular
    - Constantes vitales (tensión arterial y frecuencia cardíaca)
    - Manifestación de AE
    - Satisfacción del cirujano: La pregunta «¿Qué le parece la tolerancia global del producto del estudio?» se valorará usando la siguiente escala: 0 = muy satisfactoria, 1 = satisfactoria, 2 = no muy satisfactoria, 3 = insatisfactoria
    - Satisfacción global del paciente en la Visita 3/Día 2 (cuestionario de 5 puntos leído por un observador enmascarado).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Several timepoints (during and after surgery)
    Varios puntos de tiempo (durante y después de la cirugía)
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Last Patient Last Visit (LPLV)
    Ultima visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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: 228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 342
    F.4.2.2In the whole clinical trial 342
    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
    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 Decision2020-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-09
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