Efficacy Comparison of 2 Low-dose Atropine Eye Drops in V... | NCT05803863

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

NCT05803863

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Status

Unknown status

Last Update Posted

Apr 7, 2023Actual

Enrollment

108Estimated

Phase

Phase 4

Conditions

Myopia

Interventions

Myatro
Myatro XL

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2023Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 25, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2023

Last Update Posted Date

Apr 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thi Mong Dung Nguyen, Principal Investigator, University of Medicine and Pharmacy at Ho Chi Minh CityPrincipal Investigator

Lead Sponsor

University of Medicine and Pharmacy at Ho Chi Minh CityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myatro	Experimental	Prescribing one 0,01% Myatro (Atropine) drop/eye/night , in 12 months Then wash-out in next 12 months	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	Drug: Myatro XL
Conventional spectacles	No Intervention	Prescribing conventional spectacles and follow-up in 24 months.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myatro	Drug	myopia control with 0.01% atropine drops	Myatro	Atropine 0.01%

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
pupil size	change in pupil size (mm)	12 months
amplitude of accommodation	change in amplitude of accommodation (D)	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dung TM Nguyen, MD	Contact	(+84) 982 701 459		bsnguyenthimongdung@gmail.com

Overall Officials

Name	Affiliation	Role
Dung TM Nguyen, MD	University of Medicine and Pharmacy at Ho Chi Minh City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center HCMC		Ho Chi Minh City			Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

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Browse Branches

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