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MAD Trial: Myopia Atropine Dose

NCT05667454 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2025-04-27

No results posted yet for this study

Summary

The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.

Conditions

  • Progressive Myopia

Interventions

DRUG

Atropine Ophthalmic 0.05%

Atropine 0.05% sulphate ophthalmic solution

DRUG

Atropine Ophthalmic 0.5%

Atropine 0.5% sulphate ophthalmic solution

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • C.C.W. Klaver, Prof. Dr. · EMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2029-03-01
Completion
2029-04-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667454 on ClinicalTrials.gov