E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myopia progression |
Progresión de la miopía |
|
E.1.1.1 | Medical condition in easily understood language |
Treatment to slow the progression of myopia (short-sightedness) in children |
Trataimiento de reducir la progresión de la miopia (ser corto de vista) en niños |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028651 |
E.1.2 | Term | Myopia |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
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 |
To evaluate the safety and efficacy of 2 concentrations of Atropine Sulfate Ophthalmic Solution (0.01% and 0.02%) compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3-year treatment period. |
Evaluar la seguridad y eficacia de 2 concentraciones de una solución oftálmica de atropina sulfato (0,01% y 0,02%) comparada con el vehículo (placebo) para ralentizar la progresión de la miopía en niños durante un periodo de tratamiento de 3 años |
|
E.2.2 | Secondary objectives of the trial |
Exploratory: To observe safety and efficacy in subjects re-randomized to 1 year of treatment with Atropine Sulfate Ophthalmic Solution, 0.01% or 0.02%, or Vehicle following 3 years of treatment in children with progressive myopia. |
Exploratorio: Observar la seguridad y eficacia en sujetos realeatorizados a 1 año de tratamiento con una solución oftálmica de atropina sulfato, 0,1% o 0,02%, o con el vehículo tras 3 años de tratamiento en niños con miopía progresiva. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Children (male or female) aged 3 to < or = 17.0 years. 2. Myopia SER of at least -0.50 D and no greater than -6.00 D myopia in each eye as measured by cycloplegic autorefraction. |
1. Niños y niñas de entre 3 y ≤ 17,0 años de edad. 2. Miopía SER de al menos -0,50 D y no superior a -6,00 D de miopía en cada ojo medida mediante autorrefracción ciclopléjica. |
|
E.4 | Principal exclusion criteria |
1. If present, astigmatism more than -1.50 in either eye 2. Current or history of amblyopia or manifest strabismus. 3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity). 4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia). 5. Serious systemic illness that, in the Investigator’s opinion, would render the subject ineligible. 6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over-the-counter) other than the assigned study medication. |
1. En caso de que haya, astigmatismo de maás de -1.50 en algún ojo 2. Presencia o antecedentes de ambliopía o estrabismo manifiesto. 3. Antecedentes de cualquier enfermedad o síndrome que predisponga al sujeto a una miopía grave (p. ej. Síndrome de Marfan, síndrome de Stickler, retinopatía de la prematuridad). 4. Antecedentes en cualquiera de los ojos de anatomía refractiva ocular anormal (p. ej. queratocono, lenticono, esferofaquia). 5. Enfermedad sistémica grave que, según el criterio del investigador, no permite que el sujeto sea apto. 6. Uso crónico (más de 3 días a la semana) de cualquier medicamento oftálmico tópico (con o sin receta) que no sea el medicamento asignado del estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit. |
La diferencia total entre grupos que muestren una progresión de miopía (SER) < -0,50 D en la visita del mes 36. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Between-group difference in mean progression rates 2. Between-group difference in proportion of subjects who show <-0.75 D progression and the between-group median time to a change in myopia of <-0.75 D |
1. La diferencia de mediana en la tasa de progresión entre grupos 2. La diferencia de mediana entre grupos en la proporción de sujetos que muestran progresión <-0.75 D y el cambio en la miopía de <-0.75 D |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Month 12, Month 24, Month 36 |
Mes 12, mes 24, mes 36 |
|
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 | Yes |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 | No |
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 |
Hungary |
Ireland |
Netherlands |
United Kingdom |
United States |
|
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
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 |