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

Phase 3

Active, not recruiting

• Conditions: Myopia
• Interventions: Drug: Lower dose atropine sulfate eye drops; Drug: placebo; Drug: Low dose atropine sulfate eye drops

• Registration Number: NCT06209320
• Lead Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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.

Study Timeline

• Study Start: 2022-03-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-17
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-03
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 777

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 1	Lower dose atropine sulfate eye drops	Lower dose atropine sulfate eye drops
control group	placebo	placebo
Experimental group 2	Low dose atropine sulfate eye drops	Low dose atropine sulfate eye drops

Primary Outcome Measures

Name	Time	Method
Cycloplegic Autorefraction(SER)	24 months	Between-group difference in the mean change from baseline in SER at visit M24

Secondary Outcome Measures

Name	Time	Method
Axial Length	24 months	Between-group difference in the mean change from baseline in axial length at visit M24

Trial Locations

Locations (1)

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China