NCT06209320

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 777 (estimated)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-15
• Primary completion: 2025-03-21
• Completion: 2025-08-01
• First posted: 2024-01-17
• Last updated: 2025-07-30

Locations

1 site across 1 country: China