Investigator led, double-masked, multicentre, randomized clinical trial for the comparison of atropine 0.5% versus atropine 0.05% eye drops for the prevention of myopia progression in Dutch children

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516379-34-00

Acronym

7098

Enrollment

550

Registered

2024-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of AL in children with progressive myopia.

Detailed description

To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of SER (Spherical Equivalent of Refraction) in children with progressive myopia., To evaluate the safety, adherence, and reasons for nonresponse of atropine 0.05% compared to atropine 0.5% treatment, To evaluate the rebound effect after treatment-stop.

Interventions

DRUGAtropine 1.0% eye drops solution

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of AL in children with progressive myopia.	—

Secondary

Measure	Time frame
To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of SER (Spherical Equivalent of Refraction) in children with progressive myopia., To evaluate the safety, adherence, and reasons for nonresponse of atropine 0.05% compared to atropine 0.5% treatment, To evaluate the rebound effect after treatment-stop.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026