NCT06697522

Study of Atropine Sulfate Eye Drops(0.01%) in Treating Near-work-induced Transient Myopia in Children

A Randomized, Double-masked, Placebo-controlled, Parallel-group Study of Safety and Efficacy of Atropine Sulfate Eye Drops (0.01%) in the Treatment of Near-work-induced Transient Myopia (NITM) in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Ocumension Therapeutics (Suzhou) Co., Ltd · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of atropine sulfate eye drops (0.01%) in treating transient myopia induced by near work tasks (NITM) in pediatric subjects.

Detailed description

All eligible subjects will be randomly assigned in a 1:1 ratio to either the 0.01% atropine sulfate eye drops group or the atropine sulfate eye drops vehicle placebo control group. Subjects in the treatment group will apply one drop of 0.01% atropine sulfate eye drops to each eye before going to bed at night, while subjects in the control group will apply one drop of the atropine sulfate eye drops vehicle placebo to each eye before going to bed at night. All eligible subjects will be randomly grouped and receive treatment for a period of 12 weeks. All subjects will be followed up according to the same timing and examination schedule. The follow-up time points will be on the 1st day, 14th day, and 12th week after administration, as well as 12 weeks after discontinuation of the medication.

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	Atropine Sulfate	low concentration atropine (0.01%)
DRUG	Placebo	Blank comparator

Timeline

• Start date: 2023-06-25
• Primary completion: 2023-10-06
• Completion: 2024-03-26
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: China