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    Summary
    EudraCT Number:2022-000624-37
    Sponsor's Protocol Code Number:CLOBOF3-17IA03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-000624-37
    A.3Full title of the trial
    A Phase 3, multicenter, randomized, evaluator-blinded clinical trial to assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion, 0.05% compared to Prednisolone acetate, 1% in the treatment of inflammation after cataract surgery in pediatric population 0 to 3 years of age (CLOSE-3).
    Ensayo clínico de Fase 3, multicéntrico, aleatorizado, ciego para el evaluador, para evaluar la seguridad y eficacia de la nanoemulsión oftálmica de propionato de clobetasol al 0,05% en comparación con prednisolona acetato al 1% en el tratamiento de la inflamación después de la cirugía de cataratas en población pediátrica de 0 a 3 años.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion 0.05% compared to Prednisolone acetate, 1% in the treatment of inflammation after cataract surgery in pediatric population 0 to 3 years of age.
    Ensayo clínico para evaluar la seguridad y eficacia de clobetasol propionato 0,05% nanoemulsión oftálmica en comparación con acetato de prednisolona 1% en el tratamiento de la inflamación después de la cirugía de cataratas en población pediátrica de 0 a 3 años.
    A.3.2Name or abbreviated title of the trial where available
    CLOSE-3
    A.4.1Sponsor's protocol code numberCLOBOF3-17IA03
    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 SponsorLaboratorios Salvat, S.A.
    B.1.3.4CountrySpain
    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 supportLaboratorios Salvat, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioclever 2005 S.L.U
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressRambla Catalunya, 135, 3-1
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934086388
    B.5.6E-mailregulatory@bioclever.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 nameClobetasol propionate ophthalmic nanoemulsion, 0.05%
    D.3.2Product code Clobetasol propionate
    D.3.4Pharmaceutical form Ear/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 INNCLOBETASOL PROPIONATE
    D.3.9.1CAS number 25122-46-7
    D.3.9.2Current sponsor codeSVT-15473
    D.3.9.4EV Substance CodeSUB01346MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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 Pred Forte 10 mg/ml colirio en suspensión
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan, S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Ear/eye drops, suspension
    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 INNPREDNISOLONE ACETATE
    D.3.9.3Other descriptive namePREDNISOLONE ACETATE
    D.3.9.4EV Substance CodeSUB04014MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Inflammation and pain associated with ocular surgery.
    Inflamación y dolor después de la cirugía de cataratas.
    E.1.1.1Medical condition in easily understood language
    Inflammation and pain associated with ocular surgery.
    Inflamación y dolor después de la cirugía de cataratas.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10015943
    E.1.2Term Eye inflammation
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10015958
    E.1.2Term Eye pain
    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
    To assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion, 0.05% on ocular inflammation and pain associated with cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
    Evaluar la seguridad y eficacia de la nanoemulsión oftálmica de propionato de clobetasol al 0,05% sobre la inflamación ocular y el dolor asociados a la cirugía de cataratas en la población pediátrica de 0 a 3 años, en comparación con el colirio en suspensión de prednisolona acetato al 1%.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent.
    2. Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
    3. Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures
    4. Signed informed consent from (ICF) parents or patient’s legally authorized representative(s).
    5. Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
    6. Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade > 0).
    1. Hombre o mujer, de 0 a 3 años (que no haya cumplido los 4 años) el día de obtención del consentimiento.
    2. Pacientes candidatos a una cirugía de cataratas rutinaria en un ojo, no complicada, con o sin lente intraocular.
    3. Pacientes cuyos cuidadores estén dispuestos a cumplir con todos los procedimientos de tratamiento y seguimiento.
    4. Consentimiento informado firmado por los padres o el representante legal del paciente.
    5. Pacientes que se han sometido a una cirugía de cataratas de rutina en un ojo, no complicada, con o sin lente intraocular.
    6. Pacientes con evidencia clínica de inflamación postoperatoria (grado de inflamación de la cámara anterior > 0).
    E.4Principal exclusion criteria
    1. Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
    2. Active uveitis in the study eye.
    3. Ocular neoplasia in the study eye.
    4. Post-traumatic cataract in the study eye.
    5. Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye.
    6. Use of any topical medication in the study eye within 2 days prior to surgery, except for those required for ocular examination or preoperative preparation.
    7. Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery.
    8. Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery.
    9. Patient or patient’s breastfeeding mother who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as long as they are not used on the eyelids or surrounding area, and oral prednisolone steaglate drops as part of the standard treatment after cataract surgery) or immunosuppressants during the 30 days following cataract surgery.
    10. History of steroid-induced increase in IOP in either eye.
    11. Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically.
    12. Any current corneal abrasion or ulceration.
    13. Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components.
    14. Patients who have had ocular surgery in the study eye within 90 days prior to surgery.
    15. History of post-operative unresolved inflammation in the contralateral eye.
    16. Presence or history of chronic generalized systemic disease that the Investigator believes may either increase the risk to the subject or confound the results of the study (e.g., Diabetes mellitus, human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS]).
    17. Any other concurrent process which, in the opinion of the investigator, could impair patients’ safety or limit adherence to the study protocol.
    18. Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
    19. Prior participation in the study described in this protocol unless the patient wasn’t randomized.
    1. Presencia o sospecha de cualquier enfermedad viral, bacteriana o fúngica activa en el ojo del estudio
    2. Uveítis activa en el ojo del estudio.
    3. Neoplasia ocular en el ojo del estudio.
    4. Catarata postraumática en el ojo del estudio.
    5. Sospecha de baja visión permanente o ceguera en el ojo no estudiado. El ojo del estudio no debe ser el único ojo bueno del paciente.
    6. Uso de cualquier medicamento tópico en el ojo del estudio dentro de los 2 días anteriores a la cirugía, excepto los requeridos para el examen ocular o la preparación preoperatoria.
    7. Administración sistémica de cualquier medicamento antiinflamatorio esteroideo dentro de las 2 semanas anteriores a la cirugía.
    8. Administración sistémica de cualquier medicamento antiinflamatorio no esteroideo dentro de las 48 horas anteriores a la cirugía.
    9. Paciente o madre lactante del paciente que se espera que utilice corticosteroides (excepto inhaladores de corticosteroides y corticosteroides cutáneos, siempre y cuando no se utilicen en los párpados o en la zona circundante, y gotas de esteaglato de prednisolona oral como parte del tratamiento estándar después de la cirugía de cataratas) o inmunosupresores durante los 30 días posteriores a la cirugía de cataratas.
    10. Antecedentes de aumento de la presión intraocular inducido por esteroides en cualquiera de los dos ojos.
    11. Pacientes con glaucoma, hipertensión ocular o que recibe terapia de reducción de la presión intraocular en cualquiera de los ojos o sistémicamente.
    12. Cualquier abrasión o ulceración corneal actual.
    13. Alergia o hipersensibilidad conocida o sospechada a medicamentos similares, como otros corticosteroides, o sus componentes.
    14. Pacientes que se han sometido a cirugía ocular en el ojo de estudio dentro de los 90 días anteriores a la cirugía.
    15. Antecedentes de inflamación postoperatoria no resuelta en el ojo contralateral.
    16. Presencia o antecedentes de enfermedades sistémicas crónicas generalizadas que el investigador considere que pueden aumentar el riesgo para el sujeto o confundir los resultados del estudio (por ejemplo, diabetes mellitus, virus de la inmunodeficiencia humana [VIH] o síndrome de inmunodeficiencia adquirida [SIDA]).
    17. Cualquier otro proceso concurrente que, en opinión del investigador, pueda perjudicar la seguridad de los pacientes o limitar el cumplimiento del protocolo del estudio.
    18. Participación en cualquier estudio de un nuevo fármaco tópico o sistémico o dispositivo en investigación dentro de los 30 días anteriores a la visita de selección, o en cualquier momento durante el estudio.
    19. Participación previa en el estudio descrito en este protocolo, a menos que el paciente no haya sido aleatorizado.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with anterior chamber inflammation of grade 0.
    Porcentaje de pacientes con inflamación de la cámara anterior grado 0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3 (Day 15±2)
    Visita 3 (Día 15±2)
    E.5.2Secondary end point(s)
    • Percentage of patients with anterior chamber inflammation of grade 0.
    • Change from Baseline in the proportion of patients with different grades of anterior chamber inflammation.
    • Proportion of patients with Grade 1, Grade 2, Grade 3 and Grade 4 with anterior chamber inflammation.
    • Frequency of different signs and symptoms of ocular inflammation.
    • Change from Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score.
    • Porcentaje de pacientes con inflamación de la cámara anterior grado 0.
    • Cambio desde la visita 1 (basal) en la proporción de pacientes con diferentes grados de inflamación de la cámara anterior.
    • Proporción de pacientes con Grado 1, Grado 2, Grado 3 y Grado 4 de inflamación de la cámara anterior.
    • Frecuencia de los diferentes signos y síntomas de inflamación ocular.
    • Cambio desde la visita 1 (basal) en la puntuación de la escala de comportamiento de Cara, Piernas, Actividad, Llanto, Consolabilidad (FLACC, por sus siglas en inglés).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 (baseline, Day 1), Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).

    Note that percentage of patients with anterior chamber inflammation of grade 0 at visit 3 will be analysed as primary endpoint.
    Visita 1 (basal, Día 1) Visita 2 (Día 8±2), Visita 3 (Día 15±2), Visita 4 (Día 29±2) y Visita 5 (Día 43±3).

    Nota: El porcentaje de pacientes con inflamación de la cámara anterior grado 0 en la visita 3 se analizará como variable principal.
    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 No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Ciego para el evaluador
    Evaluator-blinded
    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 concerned6
    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
    Last patient last visit (LPLV)
    Última visita del último paciente.
    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 months8
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 25
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 35
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 state60
    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
    Niguno
    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 Decision2022-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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