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Topical 0.01% Atropine for the Control of Fast Progressing Myopia

NCT04173780 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-29

No results posted yet for this study

Summary

Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.

The management of myopia and its complications is therefore a major public health issue.

All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.

The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).

Conditions

  • Myopia Progressing
  • Childhood

Interventions

DRUG

Atropine 0.01%

1 drop per day in both eyes for 1 year

DRUG

Placebo

1 drop per day in both eyes for 1 year

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Arnaud SAUER, MD · University Hospital, Strasbourg, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2024-05-15
Completion
2024-06-03

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT04173780 on ClinicalTrials.gov