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A randomized, double-blind, placebo-controlled dose-finding study of 0.05%, 0.025%, 0.01% and 0.005% atropine eye drops to inhibit myopia progression in children in a European population
EU CTIS ID: 2024-516758-23-00
What this study is testing
To evaluate the optimal dose of low-dose atropine eye drops compared to placebo for the inhibition of myopia progression in children
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male subjects and female subjects from 6 to 12 years of age. (female subjects who cannot become pregnant and female subjects of child bearing potential (after menarche) who use an highly effective contraceptive method or strategy (failure rate per year < 1%) according to the CTFG Guidance "Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1, updated"; see Section 11.3).
- Subjects showing myopia between ≥-1.0 and ≤-4.0 D (spherical equivalent as assessed by autorefraction under cycloplegia) and a progression of myopia within the past 12 months in at least one eye.
- Parents or legal guardians who have been informed about the clinical study and have signed the informed consent form.
You likely can't join if
- Anisometropia (SE) > |1.0| D
- Previous or current alcohol or drug abuse
- Mental or emotional instability of the subject, parents or legal guardians that might jeopardize the validity of the informed consent or the compliance with the study procedures.
- Corneal astigmatism (ΔTK) > |1.5| D
- Unreliability or lack of cooperation
- History of any myopia treatment within 3 months before inclusion: e.g. DIMS glasses, Orthokeratology contact lenses, multifocal contact lenses, atropine eye drops
See the full eligibility criteria
Who can join
- Male subjects and female subjects from 6 to 12 years of age. (female subjects who cannot become pregnant and female subjects of child bearing potential (after menarche) who use an highly effective contraceptive method or strategy (failure rate per year < 1%) according to the CTFG Guidance "Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1, updated"; see Section 11.3).
- Subjects showing myopia between ≥-1.0 and ≤-4.0 D (spherical equivalent as assessed by autorefraction under cycloplegia) and a progression of myopia within the past 12 months in at least one eye.
- Parents or legal guardians who have been informed about the clinical study and have signed the informed consent form.
What rules you out
- Anisometropia (SE) > |1.0| D
- Previous or current alcohol or drug abuse
- Mental or emotional instability of the subject, parents or legal guardians that might jeopardize the validity of the informed consent or the compliance with the study procedures.
- Corneal astigmatism (ΔTK) > |1.5| D
- Unreliability or lack of cooperation
- History of any myopia treatment within 3 months before inclusion: e.g. DIMS glasses, Orthokeratology contact lenses, multifocal contact lenses, atropine eye drops
- Pregnancy
- Best corrected visual acuity VADecimal< 1.0 (VAlogMAR > 0.0)
- Pathological findings in the eyes, i.e. pathological myopia, corneal scars and pathologies in the anterior or posterior segments of the eye
- Known intolerances to atropine eye drops or known hypersensitivity to any of the other components of the investigational product, allergies against eye drops
- Presence of a contraindication for the treatment with atropine: - Hypersensitivity to the active substance or to any of the excipients. - Primary forms of glaucoma - narrow-angle glaucoma - rhinitis sicca - Narrow-angel of anterior chamber - Tachycardia, congestive heart failure, coronary stenoses - Thyrotoxicosis, hyperthyroidism - Mechanical obstruction of the gastrointestinal tract - Paralytic ileus - Megacolon - Obstructive urinary tract diseases, e.g. prostatic hypertrophy with residual urine formation - Myasthenia gravis - Acute pulmonary edema - Pregnancy toxicosis - Spastic paralysis
- Concomitant Therapy within the last 3 Months prior to Enrollment: 10. Treatment with sympathomimetics
- Down syndrome
- Concomitant Therapy within the last 3 Months prior to Enrollment: 8. Any ocular therapy other than the IMP, except for antibiotic or antiallergic eye drops
- Concomitant Therapy within the last 3 Months prior to Enrollment: 9. Treatments with - Monoamine oxidase (MAO) inhibitor therapy - Antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserine)
- Other reasons why, in the opinion of the investigator, the subjects should not participate in the study.
- Concomitant Therapy within the last 3 Months prior to Enrollment: 11. Treatment with drugs that may increase the anticholinergic effect of atropine: - Amantadine - Anti-arrhymics such as chinidine, procainamide and disopyramide - Dopamine-antagonists such as metoclopramide - Antihistaminics - Certain anti-Parkinsonian drugs (except dopamine receptor agonists) - Neuroleptics
- Concomitant Therapy within the last 3 Months prior to Enrollment: 12. Treatment with pilocarpin and physostigmine containing drugs
- Concomitant Therapy within the last 3 Months prior to Enrollment:13. Treatment with digoxine and nitrofurantoin
- Concomitant Therapy within the last 3 Months prior to Enrollment: 14. Treatment with phenothiazine
- Concomitant Therapy within the last 3 Months prior to Enrollment: 15. Treatment with levodopa
- Enrolment in another clinical study within the last 4 weeks or during enrolment in this study
- East Asian or African origin
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.