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

April 5, 2023 updated by: Thi Mong Dung Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • University Medical Center HCMC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • myopic 2 eyes (SE above from -0.75 D, astigmatism below -1.50D)
  • 8 - 13 years old
  • Vietnamese, speaking Vietnamese
  • BCVA from 8/10 each eye

Exclusion Criteria:

  • Using any contact lens in less than 3 months
  • Other eye diseases than myopia
  • History of eye trauma, surgeries
  • Having chronic systemic diseases or having medications affecting eye.
  • Having contraindications of atropine drops
  • Pre-known allergies to atropine drops
  • Undergoing another myopia control treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myatro
Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Drug: Myatro
myopia control with 0.01% atropine drops
Other Names:
  • Atropine 0.01%
Experimental: Myatro XL
Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Drug: Myatro XL
myopia control with 0.05% atropine drops
Other Names:
  • Atropine 0.05%
No Intervention: Conventional spectacles
Prescribing conventional spectacles and follow-up in 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (SE) of Atropine drops
Time Frame: 12 months
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
12 months
Efficacy (AL) of Atropine drops
Time Frame: 12 months
axial length (mm)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pupil size
Time Frame: 12 months
change in pupil size (mm)
12 months
amplitude of accommodation
Time Frame: 12 months
change in amplitude of accommodation (D)
12 months
adverse symptoms 1
Time Frame: 12 months
rate of photophobia
12 months
adverse symptoms 2
Time Frame: 12 months
rate of reading difficulties
12 months
rebound effect (SE)
Time Frame: 12 months
change in spherical equivalent (D) after wash-out (Objective cycloplegic refraction)
12 months
rebound effect (AL)
Time Frame: 12 months
change in axial length(mm) after wash-out
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 25, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137221050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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