Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05803863
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-07
First Post:
2023-03-25
Brief Title:
Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Organization:
University of Medicine and Pharmacy at Ho Chi Minh City
Study Overview
Official Title:
Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the efficacy of 2 low-dose atropine drops 001 005 in Vietnamese children The main questions it aims to answer are
1 How is the difference in efficacy among 3 groups atropine 001 vs 005 vs spectacles
2 How is the difference in side effects among 3 groups atropine 001 vs 005 vs spectacles
3 How is the difference in rebound phenomena between 2 atropine groups
1 How is the difference in efficacy among 3 groups atropine 001 vs 005 vs spectacles
2 How is the difference in side effects among 3 groups atropine 001 vs 005 vs spectacles
3 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 dropseyenight 12 months Wash-out 12 months The atropine drops in this study are commercially available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None