search
Back to results

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

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
Myatro
Myatro XL
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia control, low-dose atropin, Vietnamese children

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center HCMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Myatro

Myatro XL

Conventional spectacles

Arm Description

Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months

Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months

Prescribing conventional spectacles and follow-up in 24 months.

Outcomes

Primary Outcome Measures

Efficacy (SE) of Atropine drops
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
Efficacy (AL) of Atropine drops
axial length (mm)

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2023
Last Updated
April 5, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
search

1. Study Identification

Unique Protocol Identification Number
NCT05803863
Brief Title
Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
Official Title
Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: How is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles? How is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia control, low-dose atropin, Vietnamese children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, comparative, open label
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myatro
Arm Type
Experimental
Arm Description
Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Arm Title
Myatro XL
Arm Type
Experimental
Arm Description
Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months
Arm Title
Conventional spectacles
Arm Type
No Intervention
Arm Description
Prescribing conventional spectacles and follow-up in 24 months.
Intervention Type
Drug
Intervention Name(s)
Myatro
Other Intervention Name(s)
Atropine 0.01%
Intervention Description
myopia control with 0.01% atropine drops
Intervention Type
Drug
Intervention Name(s)
Myatro XL
Other Intervention Name(s)
Atropine 0.05%
Intervention Description
myopia control with 0.05% atropine drops
Primary Outcome Measure Information:
Title
Efficacy (SE) of Atropine drops
Description
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
Time Frame
12 months
Title
Efficacy (AL) of Atropine drops
Description
axial length (mm)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
pupil size
Description
change in pupil size (mm)
Time Frame
12 months
Title
amplitude of accommodation
Description
change in amplitude of accommodation (D)
Time Frame
12 months
Title
adverse symptoms 1
Description
rate of photophobia
Time Frame
12 months
Title
adverse symptoms 2
Description
rate of reading difficulties
Time Frame
12 months
Title
rebound effect (SE)
Description
change in spherical equivalent (D) after wash-out (Objective cycloplegic refraction)
Time Frame
12 months
Title
rebound effect (AL)
Description
change in axial length(mm) after wash-out
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dung TM Nguyen, MD
Phone
(+84) 982 701 459
Email
bsnguyenthimongdung@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dung TM Nguyen, MD
Organizational Affiliation
University of Medicine and Pharmacy at Ho Chi Minh City
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center HCMC
City
Ho Chi Minh City
Country
Vietnam
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dung TM Nguyen, MD
Phone
(+84) 982 701 459
Email
dr.dung985@ump.edu.vn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs