NCT06209281

A Phase III Clinical 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: 526 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. Subjects received the study drug in both eyes, 1 drop each time, once every night before sleep, for continuous administration.A total of 526 subjects were planned to be enrolled。 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: 2022-05-13
• Primary completion: 2023-08-20
• Completion: 2025-12-01
• First posted: 2024-01-17
• Last updated: 2025-07-30

Locations

1 site across 1 country: China