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

NCT ID: NCT06209320

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 777 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2025-08-31

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

Detailed Description

Primary objective is to evaluate the efficacy and safety of atropine sulfate eye drops versus placebo for 12 months in slowing the progression of myopia in children.

The study was designed to enroll approximately 777 subjects. Eligible subjects were randomly assigned to the placebo control group, Lower dose atropine group and Lower dose atropine group. Subjects received the study medication in both eyes, 1 drop each time, once every night at bedtime.

Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group 1

Lower dose atropine sulfate eye drops

Group Type: ACTIVE_COMPARATOR

Lower dose atropine sulfate eye drops

Intervention Type: DRUG

administer to eyes

Experimental group 2

Low dose atropine sulfate eye drops

Group Type: ACTIVE_COMPARATOR

Low dose atropine sulfate eye drops

Intervention Type: DRUG

administer to eyes

control group

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

administer to eyes

Interventions

Lower dose atropine sulfate eye drops

administer to eyes

Intervention Type: DRUG

Low dose atropine sulfate eye drops

administer to eyes

Intervention Type: DRUG

placebo

administer to eyes

Intervention Type: DRUG

Other Intervention Names

Lower dose atropine sulfate; Low dose atropine sulfate; Vehicle

Eligibility Criteria

Inclusion Criteria

1. Child (female or male) aged 6 to 12 years.

2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby cycloplegic autorefraction.

3. If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.

4. Anisometropia SER of < 1.50 D as measured by cycloplegic autorefraction.

Exclusion Criteria

1. 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;

2. Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;

3. 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;

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ningli Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ZKO-ATP-202105-China-CHAMP

Identifier Type: -

Identifier Source: org_study_id