NCT06209281

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
526

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

January 5, 2024

Last Update Submit

July 25, 2025

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Cycloplegic Autorefraction(low)

    Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with low atropine versus placebo.

    twelve months

Secondary Outcomes (2)

  • Cycloplegic Autorefraction(lower)

    twelve months

  • Cycloplegic Autorefraction(SER)

    twelve months

Other Outcomes (2)

  • Axial Length

    twelve months

  • Crystalline Lens Thickness

    twelve months

Study Arms (3)

Experimental group 1

EXPERIMENTAL

1 drop each time, once every night at bedtime

Drug: Lower dose atropine sulfate eye dropsDrug: Low dose atropine sulfate eye drops

Experimental group 2

EXPERIMENTAL

1 drop each time, once every night at bedtime

Drug: Low dose atropine sulfate eye drops

control group

EXPERIMENTAL

1 drop each time, once every night at bedtime

Drug: placebo

Interventions

Lower dose atropine sulfate eye dropsDRUG

Administer to eyes

Also known as: Eye drops
Experimental group 1
Low dose atropine sulfate eye dropsDRUG

Administer to eyes

Also known as: Eye drops
Experimental group 1Experimental group 2
placeboDRUG

Administer to eyes

Also known as: Eye drops
control group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child (female or male) aged 6 to 10 years.
  • Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by cycloplegic autorefraction.
  • If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
  • Anisometropia SER of \< 1.50 D as measured by cycloplegic autorefraction.

You may not qualify if:

  • History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
  • History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia).
  • Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year).
  • Use of cycloplegic drops for dilated ocular exam was allowable.
  • Heart rate persistently (for more than 10 minutes) \> 120 beats per minute.
  • Allergy to study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Xiaomei Qu

    Eye & ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

May 13, 2022

Primary Completion

August 20, 2023

Study Completion

December 1, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)