E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myopia control in children. |
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E.1.1.1 | Medical condition in easily understood language |
Myopia control in children. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
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 |
The primary objective is to demonstrate superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control in children of Caucasian origin, measured as change of cycloplegic refraction/year [diopter per year (D/year)] after one year of treatment. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to compare atropine 0.02% and placebo with respect to axial eye length increase/year [mm/year], visual acuity at distance and at near, pupil size, accommodation, and safety regarding ocular and systemic side effects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients aged 8 to 12 years (up to the day before the 13th birthday) 2. Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia 3. Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws 4. Ability to understand the nature of the trial and the trial related procedures and to comply with them
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E.4 | Principal exclusion criteria |
1. Asian or African origin 2. Abnormal binocularity 3. Strabismus 4. Astigmatism >1.5 D 5. Anisometropia >1.5 D 6. History of amblyopia 7. Corrected visual acuity in any eye <0.63 8. Any acquired or developmental organic eye disease 9. Premature birth 10. Any known systemic metabolic disease or chromosomal anomaly 11. Previous use of any kind of contact lenses 12. Previous use of atropine eye drops 13. Epilepsy 14. Known hypersensitivity to the active substances or any of the excipients 15. Participation in any other interventional clinical trial within the last 30 days before the start of this trial 16. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed 17. Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca 18. Caution and pediatric counselling shall be assured if any of the following conditions are present according to the Summary of Product Characteristics (SmPC): Cardiac insufficiency, arrhythmia, coronary stenosis, hyperthyroidism, stomach or bowel stenosis, bowel paralysis, megacolon, muscle weakness, lung edema, hypersensitivity to atropine, spastic paralysis 19. Parents or children with poor understanding of the German language 20. Person who is in a relationship of dependence/employment with the sponsor or the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: Change of cycloplegic refraction/year [D/year] after 1 year of treatment.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 1 year of treatment. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints: Axial eye length change/year [mm/year] after 1 year. Categorized rate of change in refraction and eye length after 1 year.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 1 year of treatment. |
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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 | Yes |
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 | Yes |
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 20 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |