E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glaucoma o hipertensión ocular // Glaucoma or ocular hipertension |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018304 |
E.1.2 | Term | Glaucoma |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | Ocular hypertension |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluar la seguridad a largo plazo de LUM al 0,01% comparado con LUM al 0,03% administrado una vez al día durante 2 años en pacientes con glaucoma o hipertensión ocular. // To evaluate the long-term safety of LUM 0.01% compared with LUM 0.03% administered once daily for 2 years in patients with glaucoma or ocular hypertension |
|
E.2.2 | Secondary objectives of the trial |
No aplicable // Not applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Hombre o mujer, de al menos 18 años. 2. El paciente tiene HTO, glaucoma primario de ángulo abierto, glaucoma crónico de ángulo cerrado con iridotomía/iridectomía manifiesta, glaucoma pseudoexfoliativo o glaucoma pigmentario en cada ojo. 3. El paciente necesita tratamiento reductor de la PIO bilateral y es probable que se controle su PIO con monoterapia de bimatoprost. 4. Inicio: puntuación de mejor agudeza visual corregida equivalente a una agudeza de Snellen de 20/100 o mejor en cada ojo, utilizando una tabla de agudeza visuallogarítmica para comprobaciones a 3 metros (10 pies) 5. Inicio: prueba de embarazo en orina negativa para mujeres en edad fértil antes de la asignación aleatoria. 6. Consentimiento informado por escrito obtenido antes de cualquier procedimiento del estudio. 7. El paciente es capaz de seguir las instrucciones del estudio y está dispuesto a ello y es probable que complete todas las visitas requeridas 8. Documentación escrita obtenida de acuerdo con los requisitos de confidencialidad locales y nacionales relevantes, si es aplicable (por ejemplo, consentimiento escrito sobre Protección de datos [centros de la Unión Europea]). //
1. Male or female, at least 18 years of age and of legal age of consent 2. Patient has either OHT, chronic open-angle glaucoma, chronic angle-closure glaucoma with patent iridotomy/iridectomy, pseudoexfoliative glaucoma, or pigmentary glaucoma in each eye 3. Patient requires bilateral IOP-lowering therapy and his/her IOP is likely to be controlled on bimatoprost monotherapy 4. Baseline: A best-corrected visual acuity score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters) 5. Baseline: Negative urine pregnancy test for females of childbearing potential prior to randomization 6. Written informed consent has been obtained prior to any study procedures 7. Patient is able and willing to follow study instructions and likely to complete all required visits 8. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, written Data Protection consent [sites in European Union]). |
|
E.4 | Principal exclusion criteria |
1. Enfermedad sistémica no controlada. 2. Mujeres embarazadas, en periodo de lactancia o que estén planeando un embarazo o mujeres en edad fértil y que no utilicen un Método anticonceptivo fiable. 3. Pacientes con enfermedad avanzada en la superficie ocular o con afectación de la córnea. 4. Presunta reacción adversa previa a la exposición a PGA o BAK que ha conducido al abandono de la medicación 5. Alergia o hipersensibilidad conocidas al medicamento del estudio o a sus componentes 6. Alergia o contraindicación al uso de fluoresceína tópica, verde de lisamina o algún otro producto de diagnóstico necesario para los procedimientos de examen del estudio 7. Enfermedad ocular activa o recurrente que, en opinión del investigador, interferiría en la interpretación de los datos del estudio 8. Exposición crónica conocida a causas de irritación de la superficie ocular 9. Antecedentes de alergias estacionales oculares recurrentes en los 2 últimos años 10. Cualificación/inicio (día 1): hallazgos activos en la superficie ocular, sequedad igual a +1) o más en cualquier ojo. investigación o participación en dicho estudio en los 30 días anteriores a la cualificación/inicio (día 1) 1. Uncontrolled systemic disease 2. Females who are pregnant, nursing, or planning a pregnancy or females of childbearing potential, not using a reliable method of contraception. A female is considered to be of childbearing potential unless she is without a uterus or is post-menopausal and has been amenorrheic for at least 12 consecutive months. 3. Patients with advanced ocular surface disease (eg, dry eye) or in whom the cornea is compromised 4. Previous suspected adverse reaction to either PGA or to BAK exposure that has led to discontinuation of medication 5. Known allergy or hypersensitivity to the study medication or its components 6. Allergy or contraindication to the use of topical fluorescein, lissamine green or any other diagnostic agent needed for study examination procedures 7. Active or recurrent ocular disease (eg, uveitis, ocular infections, chronic blepharitis, or moderate to severe dry eye), that in the opinion of the investigator would interfere with the interpretation of the study data 8. Known chronic exposure to causes of ocular surface irritation (eg, smoke, chlorine) 9. History of recurrent ocular seasonal allergies within the past 2 years 10. Qualification/Baseline (day 1): Active ocular surface findings (eg, hyperaemia or irritation) equal to +1 (mild) or greater in either eye found on gross macroscopic hyperaemia or slit-lamp examination Para más información, por favor consultar el protocolo. // Please refer to protocol for further information. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Las notificaciones de uno o más acontecimientos adversos relacionados con el tratamiento y que afectan a la superficie ocular constituirán la variable principal. Se calculará la proporción de pacientes que notifican acontecimientos adversos en la superficie ocular relacionados con el tratamiento a lo largo de los 2 años de duración del estudio en cada grupo de tratamiento. //
Reports of one or more treatment-related adverse events associated with the ocular surface will be the primary variable. The proportion of patients reporting treatment-related ocular surface adverse events over the 2-year course of the study in each treatment group will be calculated. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial 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
|
Última visita del último paciente en el estudio. // Last patient last visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |