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

NCT06209320 | Active Not Recruiting Phase 3

• 1 other identifier: ZKO-ATP-202105-China-CHAMP
• Study Type: interventional
• Target: 777
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops in slowing the progression of myopia in children

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Cycloplegic Autorefraction(SER)

  Between-group difference in the mean change from baseline in SER at visit M24

  24 months

Secondary Outcomes (1)

• Axial Length

  24 months

Other Outcomes (1)

• Relationship between age and slow myopia progression

  24 months

Study Arms (3)

Experimental group 1

ACTIVE COMPARATOR

Lower dose atropine sulfate eye drops

Drug: Lower dose atropine sulfate eye drops

Experimental group 2

ACTIVE COMPARATOR

Low dose atropine sulfate eye drops

Drug: Low dose atropine sulfate eye drops

control group

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Lower dose atropine sulfate eye drops DRUG

administer to eyes

Also known as: Lower dose atropine sulfate

Experimental group 1

Low dose atropine sulfate eye drops DRUG

administer to eyes

Also known as: Low dose atropine sulfate

Experimental group 2

placebo DRUG

administer to eyes

Also known as: Vehicle

control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child (female or male) aged 6 to 12 years.
• Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby 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:

• Have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); Only single vision glasses are allowed for myopia correction;
• Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;
• Use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; Allowing for tests such as cycloplegic optometry;

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Ningli Wang

  Beijing Tongren Hospital

  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 6, 2024
• First Posted: January 17, 2024
• Study Start: March 15, 2022
• Primary Completion: March 21, 2025
• Study Completion: August 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CN (1)