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A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops

NCT06209281 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2025-07-30

No results posted yet for this study

Summary

This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.

Conditions

  • Myopia

Interventions

DRUG

Lower dose atropine sulfate eye drops

Administer to eyes

DRUG

Low dose atropine sulfate eye drops

Administer to eyes

DRUG

placebo

Administer to eyes

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaomei Qu · Eye & ENT Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2023-08-20
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT06209281 on ClinicalTrials.gov