MyopiaPhase 4NCT05803863
Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
A Phase 4 study testing Myatro and Myatro XL in people with Myopia, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- Myatro and Myatro XL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Apr 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University Medical Center HCMC
Ho Chi Minh City
Dung TM Nguyen, MD, (+84) 982 701 459, dr.dung985@ump.edu.vn
About this study
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?
Read the 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
- Being tested
- Myatro, Myatro XL
- Keywords
- myopia control, low-dose atropin, Vietnamese children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyatroDrug
Also called Atropine 0.01%
myopia control with 0.01% atropine drops
Myatro XLDrug
Also called Atropine 0.05%
myopia control with 0.05% atropine drops
| Study group | Role | What they receive |
|---|---|---|
| Myatro | Experimental | Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months Receives: Drug: Myatro |
| Myatro XL | Experimental | Prescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months Receives: Drug: Myatro XL |
| Conventional spectacles | No intervention | Prescribing conventional spectacles and follow-up in 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (SE) of Atropine drops
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
Measured: 12 months
Efficacy (AL) of Atropine drops
axial length (mm)
Measured: 12 months
Secondary outcomes (6)
pupil size
change in pupil size (mm)
Measured: 12 months
amplitude of accommodation
change in amplitude of accommodation (D)
Measured: 12 months
adverse symptoms 1
rate of photophobia
Measured: 12 months
adverse symptoms 2
rate of reading difficulties
Measured: 12 months
rebound effect (SE)
change in spherical equivalent (D) after wash-out (Objective cycloplegic refraction)
Measured: 12 months
rebound effect (AL)
change in axial length(mm) after wash-out
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Apr 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, comparative, open label
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thi Mong Dung Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Dung TM Nguyen, MD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803863
- Sponsor's protocol ID
- 137221050
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
- ClinicalTrials.gov ID
- NCT05803863
- Acronym / sponsor ID
- 137221050
- Conditions
- Myopia
- Keywords
- myopia control, low-dose atropin, Vietnamese children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, comparative, open label
| Arm | Type | Receives |
|---|---|---|
| Myatro | Experimental | Drug: MyatroPrescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months |
| Myatro XL | Experimental | Drug: Myatro XLPrescribing one 0,05% Myatro XL (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months |
| Conventional spectacles | No intervention | –Prescribing conventional spectacles and follow-up in 24 months. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyatroAlso: Atropine 0.01%myopia control with 0.01% atropine drops | Drug | Myatro |
| Myatro XLAlso: Atropine 0.05%myopia control with 0.05% atropine drops | Drug | Myatro XL |
Primary outcome
Efficacy (SE) of Atropine drops
Time frame: 12 months
measured by change in spherical equivalent (D) (Objective cycloplegic refraction)
Efficacy (AL) of Atropine drops
Time frame: 12 months
axial length (mm)
6 secondary outcomes
pupil size
Time frame: 12 months
amplitude of accommodation
Time frame: 12 months
adverse symptoms 1
Time frame: 12 months
adverse symptoms 2
Time frame: 12 months
rebound effect (SE)
Time frame: 12 months
rebound effect (AL)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dung TM Nguyen, MD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myatro and Myatro XL in people with Myopia, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dung TM Nguyen, MD ((+84) 982 701 459, bsnguyenthimongdung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (SE) of Atropine drops (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.