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Low-dose AtropIne for Myopia control in children
EU CTIS ID: 2024-513091-17-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
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 or female patients aged 8 to 12 years (up to the day before the 13th birthday)
- Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
- Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
You likely can't join if
- Asian or African origin
- Any known systemic metabolic disease or chromosomal anomaly
- Previous use of any kind of contact lenses
- Previous use of atropine eye drops
- Epilepsy
- Known hypersensitivity to the active substances or any of the excipients
See the full eligibility criteria
- Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
- Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
- Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
- Asian or African origin
- Any known systemic metabolic disease or chromosomal anomaly
- Previous use of any kind of contact lenses
- Previous use of atropine eye drops
- Epilepsy
- Known hypersensitivity to the active substances or any of the excipients
- Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
- 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
- Parents or children with poor understanding of the German language
- Abnormal binocularity
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
- Strabismus
- Astigmatism >1.5 D
- Anisometropia >1.5 D
- History of amblyopia
- Corrected visual acuity in any eye <0.63
- Any acquired or developmental organic eye disease
- Premature birth
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.