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

Myopia Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06209320
Study type Interventional
Source Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 15, 2022
Completion date August 2025
View Details
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