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

NCT05803863 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-04-07

No results posted yet for this study

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?

Conditions

  • Myopia

Interventions

DRUG

Myatro

myopia control with 0.01% atropine drops

DRUG

Myatro XL

myopia control with 0.05% atropine drops

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Principal Investigators

  • Dung TM Nguyen, MD · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05803863 on ClinicalTrials.gov