Low-dose AtropIne for Myopia control in children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513091-17-00

Acronym

P001307

Enrollment

300

Registered

2024-10-24

Start date

2021-09-29

Completion date

Unknown

Last updated

2024-10-24

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

Conditions

Progressive myopia

Brief summary

Change of cycloplegic refraction/year [D/year] after 1 year of treatment.

Detailed description

Axial eye length change/year [mm/year] after 1 year., Categorized rate of change in refraction and eye length after 1 year.

Interventions

DRUGAtropine Sulfate 0.02% eye drops

DRUGsolution

DRUGAtropine Sulfate 0.01% eye drops

DRUGEye drops

DRUGsolution. Apart from the active substance identical to the IMP.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change of cycloplegic refraction/year [D/year] after 1 year of treatment.	—

Secondary

Measure	Time frame
Axial eye length change/year [mm/year] after 1 year., Categorized rate of change in refraction and eye length after 1 year.	—

Countries

Germany

Outcome results

None listed

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