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Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

NCT05597163 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2023-01-11

No results posted yet for this study

Summary

To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.

Conditions

  • Myopia, Progressive

Interventions

DRUG

low concentration atropine (0.01%)

0.01% atropine eye drop

DRUG

low concentration atropine (0.025%)

0.025% atropine eye drop

DRUG

low concentration atropine (0.05%)

0.05% atropine eye drop

DRUG

Placebo

Placebo eye drop

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Shandong University of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Principal Investigators

  • Haidong Zou · Shanghai Eye Disease Prevention and Treatment Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-11-01
Completion
2025-11-01

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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 NCT05597163 on ClinicalTrials.gov