NCT05803863

Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy of 2 low-dose atropine drops (0,01%; 0,05%) in Vietnamese children. The main questions it aims to answer are: 1. How is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles? 2. How is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles? 3. How is the difference in rebound phenomena between 2 atropine groups?

Detailed description

The study is prospective, comparative, open label. Participants are Vietnamese children. Prescribing drops : 1 drops/eye/night/ 12 months Wash-out: 12 months The atropine drops in this study are commercially available.

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	Myatro	myopia control with 0.01% atropine drops
DRUG	Myatro XL	myopia control with 0.05% atropine drops

Timeline

• Start date: 2023-04-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: Vietnam