E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myopia- a refractive error due to a discrepancy between the anatomical axial length and the focal length of the eye. resulting in distant objects appearing blurred |
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E.1.1.1 | Medical condition in easily understood language |
Myopia, also commonly referred to as shortsightedness, results in distant objects appearing blurred |
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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 |
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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 determine efficacy of 0.01% atropine eye drops in the management of myopic progression.
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E.2.2 | Secondary objectives of the trial |
To determine the structural basis of action of atropine by biometric analysis of the treatment and control groups. To develop a quantitative risk model for myopic progression based on parental and participant ocular biometric factors. To inspect any rebound acceleration in myopia in the 12 months following cessation of low-dose atropine treatment and compare this to a slow tapering withdrawal of treatment. To determine the safety of low dose atropine therapy based on a) the efficacy of treatment in managing myopia progression b) adverse events during trial c) risk of atropine therapy and d) risk of examination procedures. To determine the acceptability of low dose atropine eye drops (0.01% and 0.05%) in the management of myopic progression based on analysis of a) the efficacy of treatment b) the difference in QoL questionnaire scores between intervention and control groups c) the occurrence of adverse events d) proportion of participants needing bifocals and e) the drop-out rate. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible for inclusion, each child must have spherical equivalent refractive error of -1.0D or worsewith myopia progression of at least -0.50DS over the last year, based on refractive or clinical evidence. They must have astigmatism less than or equal to -2.50D and an intraocular difference in spherical equivalent <= 1D. Their corrected visual acuity must be better or equal to logMAR 0.2in both eyes and ifference between non-cycloplegic and cycloplegic spherical refraction of less than 1.00 D. Participants must have normal IOP (<= 21mmHg), normal ocular health and good general health with no history of cardiac/respiratory diseases. Participants must have willingness to commit to the 2 year clinical trial as well as randomisation to the placebo. |
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E.4 | Principal exclusion criteria |
Any child meeting any of the exclusion criteria at the baseline visit will be excluded from study participation: •Ocular/systemic diseases/conditions affecting vision or refractive error •Any ocular/systemic condition wherein atropine is contraindicated •Known allergy to atropine, cyclopentolate hydrochloride and/or proxymetacaine hydrochloride •Defective binocular vision, amblyopia or strabismus •Any other conditions precluding adherence to the protocol including allergy to study eye drops (active agent or preservative) •Previous pharmaceutical or optical myopia control interventions •Subjects (or parent/guardian) unable to provide written informed consent Subjects (or parent/guardian) unable to provide written informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Spherical cycloplegic refraction |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change in Spherical cycloplegic refraction from 24-36 months |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 4 |
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 | 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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |