NCT05597163

Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 588 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DRUG	low concentration atropine (0.01%)	0.01% atropine eye drop
DRUG	low concentration atropine (0.025%)	0.025% atropine eye drop
DRUG	low concentration atropine (0.05%)	0.05% atropine eye drop
DRUG	Placebo	Placebo eye drop

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-11-01
• Completion: 2025-11-01
• First posted: 2022-10-27
• Last updated: 2023-01-11