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    Summary
    EudraCT Number:2020-000438-16
    Sponsor's Protocol Code Number:LT2347-PIV-02/20
    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:2020-07-20
    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 number2020-000438-16
    A.3Full title of the trial
    RANDOMIZED SINGLE-BLIND CLINICAL TRIAL TO STUDY THE TOLERABILITY, EFFICACY, QUALITY OF LIFE, AND ADHERENCE OF FIXAPROST® COMPARED TO GANFORT® P IN PATIENTS WITH OPEN-ANGLE GLAUCOMA AND/OR OCULAR HYPERTENSION.
    Ensayo Clínico randomizado de ciego simple para estudiar la tolerabilidad, eficacia, calidad de vida y adherencia a Fixaprost ® comparado con Ganfort® en pacientes con Glaucoma de ángulo abierto y/o Hipertensión ocular.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AdEQUATE study: Efficacy, Quality of life, Adherence and Tolerability of Fixaprost®
    Estudio AdEQUATE: Eficacia, calidad de vida, adherencia y tolerabilidad de Fixaprost®
    A.3.2Name or abbreviated title of the trial where available
    AdEQUATE Study
    AdEQUATE Study
    A.4.1Sponsor's protocol code numberLT2347-PIV-02/20
    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 Théa S.A.S
    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 S.A.S
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Thea, S.A.
    B.5.2Functional name of contact pointFarmacovigilancia
    B.5.3 Address:
    B.5.3.1Street AddressC/ Enric Granados, 86-88, 2ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number34934766810
    B.5.6E-mailGlobal.PV.PMS@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 Yes
    D.2.1.1.1Trade name FIXAPROST
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires THEA S.A.S
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLATANOPROST
    D.3.9.3Other descriptive nameLATANOPROST
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL
    D.3.9.3Other descriptive nameTIMOLOL
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEar/eye 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
    Open angle glaucoma and ocular hypertension
    Glaucoma de ángulo abierto e hipertensión ocular
    E.1.1.1Medical condition in easily understood language
    Patients with Open-Angle Glaucoma or Ocular Hypertension, previously treated with a prostaglandin analogue monotherapy
    Pacientes con glaucoma de angulo abierto o hipertension ocular, previamente tratados con un anlogo de prostaglandina en monoterapia
    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 10030348
    E.1.2Term Open angle glaucoma
    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 10030043
    E.1.2Term Ocular hypertension
    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 compare conjunctival hyperemia between preservative-free latanoprost/timolol fixed combination (Fixaprost®) and preserved bimatoprost/timolol fixed combination (Ganfort® P) in patients with open-angle glaucoma or ocular hypertension, and who had previously been treated with a prostaglandin analogue (PGA) monotherapy.
    Comparar la hiperemia conjuntival entre la combinación fija de latanoprost / timolol sin conservantes (Fixaprost®) y la combinación fija de bimatoprost / timolol con conservantes (Ganfort® P) en pacientes con glaucoma de ángulo abierto o hipertensión ocular, y que habían sido tratados previamente con un análogo de prostaglandina (PGA) monoterapia.
    E.2.2Secondary objectives of the trial
    - To evaluate the conjunctival hyperemia in the different groups of patients, according to the previous PGA treatment.
    - The health-related quality of life (HR-QoL).
    - To compare treatment compliance.
    - To compare the general tolerability.
    - To investigate the tolerability parameters that influence HR-QoL and compliance.
    - To assess the changes in ocular signs, symptoms and the related discomfort when using display screens.
    - To assess the differences in the use of tears substitutes (between the IMP) and the changes (from the previous treatments).
    - To assess the patients’ and physicians’ satisfaction with treatment (visual analog scale, VAS).
    - To compare the general tolerability of the study treatments versus previous PGA treatment (monotherapy).
    - To compare the mean IOP values at Month 1 and Month 3 visits.
    - Evaluar la hiperemia conjuntival en los diferentes grupos de pacientes, según el tratamiento previo con PGA.
    - La calidad de vida relacionada con la salud (HR-QoL).
    - Comparar el cumplimiento del tratamiento.
    - Comparar la tolerabilidad general.
    - Investigar los parámetros de tolerabilidad que influyen en la calidad de vida y el cumplimiento.
    - Evaluar los cambios en los signos oculares, los síntomas y las molestias relacionadas al usar pantallas.
    - Evaluar las diferencias en el uso de colirio (entre el IMP) y los cambios (de los tratamientos anteriores).
    - Evaluar la satisfacción de los pacientes y los médicos con el tratamiento (escala analógica visual, VAS).
    - Comparar la tolerabilidad general de los tratamientos del estudio versus el tratamiento previo con PGA (monoterapia).
    - Comparar los valores medios de la PIO en las visitas del mes 1 y del mes 3.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub-study will be performed in the sites Hospital de la Santa Creu i Sant Pau with Dr. Tellez and the Hosp. Univ. Reina Sofia with Dr. Giménez to assess the inflammatory cytokine profile in tears after 3 months of treatment with the IMP. Analysis will be centralized in Hospital de la Santa Creu i Sant Pau.
    Se realizará un subestudio en los centros Hospital de la Santa Creu i Sant Pau con el Dr. Tellez y en el Hosp. Univ. Reina Sofia con el Dr. Giménez , para evaluar el perfil inflamatorio de citoquinas en las lágrimas después de 3 meses de tratamiento con el IMP. El análisis se centralizará en el Hospital de la Santa Creu i Sant Pau.
    E.3Principal inclusion criteria
    1. Men or women aged ≥ 18 years at the time of the agreement.
    2. Patients with documented diagnosis of mild to moderate open-angle glaucoma (visual field loss more than 10 dB; cupping 0.8 or less) or ocular hypertension. Patients with pseudoexfoliative or pigmentary glaucoma can be included.
    3. Both eyes must have received treatment with PGA monotherapy for 3 months or longer at the time of baseline examination.
    4. Patients judged by their treating doctors to require additional ophthalmic medication due to the progression of visual field defects or uncontrolled IOP despite their continued treatment and whose IOP is between 16 and 28 mmHg.
    5. Patients who are judged to require to switch to a PGA/Beta-blocker fixed combination as they are not able to achieve target IOP on their current IOP-lowering PGA monotherapy. Patients treated by oral Beta-blockers for cardiac/vascular disease can be recruited, under the investigator criteria.
    6. Distance best corrected Snellen Visual Acuity at least 20/80 or –LogMAR at least 0.6.
    7. Patients who can understand the instructions and adhere to medications.
    8. Patients who received complete information regarding the study objectives and signed a written informed consent before entering in the study.
    1. Hombres o mujeres de edad ≥ 18 años en el momento del acuerdo.
    2. Pacientes con diagnóstico documentado de glaucoma de ángulo abierto de leve a moderado (pérdida del campo visual de más de 10 dB; ventosas de 0.8 o menos) o hipertensión ocular. Se pueden incluir pacientes con glaucoma pseudoexfoliativo o pigmentario.
    3. Ambos ojos deben haber recibido tratamiento con monoterapia con PGA durante 3 meses o más al momento del examen inicial.
    4. Los pacientes juzgados por sus médicos tratantes que requieren medicación oftálmica adicional debido a la progresión de defectos del campo visual o PIO no controlada a pesar de su tratamiento continuo y cuya PIO es entre 16 y 28 mmHg.
    5. Pacientes que se considera que requieren cambiar a una combinación fija de PGA / Betabloqueante ya que no pueden alcanzar la PIO objetivo en su monoterapia con PGA para reducir la PIO actual. Los pacientes tratados con betabloqueantes orales para la enfermedad cardíaca / vascular pueden ser reclutados, según los criterios del investigador.
    6. La distancia mejor corregida Agudeza visual de Snellen al menos 20/80 o –LogMAR al menos 0.6.
    7. Pacientes que pueden entender las instrucciones y adherirse a los medicamentos.
    8. Pacientes que recibieron información completa sobre los objetivos del estudio y firmaron un consentimiento informado por escrito antes de ingresar al estudio.
    E.4Principal exclusion criteria
    1.Patients treated with current topical monotherapies with Beta-blocker, Carbonic Anhydrase Inhibitor and Alpha 2-agonist or all bitherapies (fixed or unfixed).
    2.Patients needing another IOP-lowering drug other than those to be used in the study.
    3.Patients using systemic administration of an oral Carbonic Anhydrase Inhibitor (acetazolamide, etc.) for a different reason than glaucoma.
    4.Severe glaucoma (Visual Field performed in the last 6 months: threshold 10 db).
    5.Diagnosed severe dry eye.
    6.History of ocular inflammation or past use of steroids (within 2 months), except mild blepharitis
    7.History of atopy or ocular allergy.
    8.Sign of ocular infection.
    9.Aphakic eyes.
    10.Any abnormality preventing accurate assessment, e.g. reliable tonometry measurement, corneal/conjunctival examination, visual field examination, fundus examination.
    11.Palpebral mechanical abnormalities.
    12.Diabetic Macular Edema or severe Diabetic Retinopathy.
    13.Ocular fundus abnormalities other than related to glaucoma.
    14.Chronic or recurrent uveitis, scleritis or corneal herpes.
    15.History of ocular trauma.
    16.History of previous clinically significant ocular disease.
    17.History of corneal refractive surgery.
    18.Intraocular surgery or laser ocular procedure (SLT, ALT, iridotomy…) within 6 months before baseline examinations.
    19.User of contact lenses.
    20.Pregnant patient or lactating mother.
    21.Any acute or uncontrolled disease or psychiatric illness or severe dementia that could prevent accurate study assessments.
    22.Participation in any investigational study within the last 30 days.
    23.Patients who are judged inappropriate for participation in the study for other reason.
    24.History of non-compliance.
    25.Known medical history of allergy or contraindication to Beta-blockers.
    26.Known allergy to any of the excipients of the IMPs.
    1.Pacientes en tratamiento con monoterapia tópica con betabloqueantes, inhibidores de la anhidrasa carbónica o agonistas alpha-2 o con cualquier biterapia (en combinación fija o no fija).
    2.Pacientes que necesiten un fármaco para reducir la PIO distinto a los que se van a usar en el estudio.
    3.Pacientes con administración sistémica de inhibidores de la anhidrasa carbónica (acetazolamida, …) orales por una razón distinta al glaucoma.
    4.Glaucoma severo (campo visual realizado en los últimos 6 meses: umbral 10dB)
    5.Diagnóstico de ojo seco severo.
    6.Historia de inflamación ocular o uso en el pasado de esteroides (dentro de los 2 últimos meses), excepto blefaritis leve.
    7.Historia de atopia o alergia ocular.
    8.Signos de infección ocular.
    9.Ojos afáquicos
    10.Cualquier anormalidad que impida una evaluación precisa, p. ej. medición de tonometría confiable, examen corneal / conjuntival, examen de campo visual, examen de fondo de ojo.
    11.Anomalías mecánicas palpebrales.
    12.Edema macular diabético (o retinopatía diabética severa).
    13.Anomalías en el fondo ocular, aparte de aquellas relacionadas con el glaucoma.
    14.Uveítis crónica o recurrente, escleritis o herpes corneal.
    15.Historia de trauma ocular.
    16.Historia de enfermedades oculares clínicamente significativas.
    17.Historia de cirugía corneal refractiva.
    18.Cirugía intraocular o cirugía ocular láser (SLT, ALT, iridotomía, …) dentro de los últimos 6 meses anteriores a la visita basal.
    19.Uso de lentes de contacto.
    20.Paciente embarazada o en período de lactancia.
    21.Cualquier enfermedad aguda o no controlada o enfermedad psiquiátrica o demencia severa que pueda impedir las evaluaciones precisas del estudio.
    22.Participación en cualquier estudio de investigación dentro de los últimos 30 días.
    23.Pacientes que se consideran inapropiados para participar en el estudio por otro motivo.
    24.Historia de falta de adherencia.
    25.Historial médico conocido de alergia o contraindicación a los betabloqueantes.
    26.Alergia conocida a cualquiera de los excipientes de los productos en investigación.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be based on the grade and the score of conjunctival hyperemia, measured by the McMonnies scale and the Nidek® automated software respectively, after one month of treatment with preservative-free latanoprost/timolol fixed combination (Fixaprost®) versus preserved bimatoprost/timolol fixed combination (Ganfort® P).
    El criterio de valoración principal se basará en el grado y la puntuación de la hiperemia conjuntival, medida por la escala McMonnies y el software automatizado Nidek® respectivamente, después de un mes de tratamiento con combinación fija de latanoprost / timolol sin conservantes (Fixaprost®) versus la combinación fija de bimatoprost / timolol con conservantes (Ganfort® P).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be evaluated once, at visit 1 (1 month after treatment initiation).
    Se evaluará una vez, en la visita 1 (1 mes después del inicio del tratamiento).
    E.5.2Secondary end point(s)
    The HR-QoL will be based on the validated questionnaire Comparison of Ophthalmic Medications for Tolerability (COMToL®), specifically designed for its use in clinical trials comparing ophthalmic medications.
    Treatment compliance will be assessed as the score of the Morisky 8-Item Medication Adherence Scale (MMAS-8).
    The general tolerability of the investigated and previous treatments will be assessed based on the symptoms listed in the COMToL® questionnaire .
    Discomfort when using display screens will be assessed with a visual analog scale (VAS) by the patient.
    The use of tear substitutes will be registered at baseline, and at each study visit, it will be assessed as increased, not modified, decreased, or stopped from the last visit.
    Satisfaction regarding tolerability with treatment will be measured using a VAS by the patient and by the physician at each study visit.
    IOP will be measured in both eyes by a calibrated Goldmann applanation tonometer at each study visit.
    La HR-QoL se basará en el cuestionario validado Comparación de medicamentos oftálmicos para la tolerabilidad (COMToL®), diseñado específicamente para su uso en ensayos clínicos que comparan medicamentos oftálmicos.
    El cumplimiento del tratamiento se evaluará como la puntuación de la Escala de adherencia a la medicación de 8 elementos de Morisky (MMAS-8).
    La tolerabilidad general de los tratamientos investigados y anteriores se evaluará en función de los síntomas enumerados en el cuestionario COMToL®.
    El paciente evaluará las molestias al utilizar pantallas de visualización con una escala analógica visual (VAS).
    El uso de sustitutos lagrimales se registrará al inicio del estudio y, en cada visita de estudio, se evaluará como aumentado, no modificado, disminuido o suspendido desde la última visita.
    La satisfacción con respecto a la tolerabilidad con el tratamiento se medirá utilizando un VAS por el paciente y por el médico en cada visita de estudio.
    La PIO se medirá en ambos ojos mediante un tonómetro de aplanamiento Goldmann calibrado en cada visita de estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoints will be assessed at baseline, and at Months 1 and 3 of treatment. Baseline assessments will be associated with previous PGA treatment, and Months 1 and 3 assessments will be associated with the IMPs according to the previous PGA treatment.
    Se evaluarán al inicio del estudio y en los meses 1 y 3 de tratamiento. Las evaluaciones de referencia se asociarán con el tratamiento previo de PGA, y las evaluaciones de los meses 1 y 3 se asociarán con los IMP de acuerdo con el tratamiento previo de PGA.
    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 No
    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 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 concerned10
    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 (última visita, último sujeto)
    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.1.1.1In 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state200
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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