Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents (LAMC)
Primary Purpose
Myopia, Progressive
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low concentration atropine (0.01%)
low concentration atropine (0.025%)
low concentration atropine (0.05%)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive
Eligibility Criteria
Inclusion Criteria:
- The age of the screening stage is 3-15 years, both sexes;
- One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
- Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
- Informed consent from the guardian and the child.
Exclusion Criteria:
- strabismus, amblyopia or other ocular abnormalities;
- The presence of systemic disease abnormalities;
- have taken myopia control treatment in the past month;
- Allergic to low concentration atropine or sulfuric acid drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
0.01% atropine
0.025% atropine
0.05% atropine
cross-over
Arm Description
0.01% atropine eye drop
0.025% atropine eye drop
0.05% atropine eye drop
first year: placebo second year: 0.05% atropine eye drop
Outcomes
Primary Outcome Measures
Proportion of SE changes over -0.75D
Secondary Outcome Measures
AL change
Full Information
NCT ID
NCT05597163
First Posted
October 24, 2022
Last Updated
January 9, 2023
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Peking University People's Hospital, Shandong University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05597163
Brief Title
Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
Acronym
LAMC
Official Title
A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Peking University People's Hospital, Shandong University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
588 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.01% atropine
Arm Type
Experimental
Arm Description
0.01% atropine eye drop
Arm Title
0.025% atropine
Arm Type
Experimental
Arm Description
0.025% atropine eye drop
Arm Title
0.05% atropine
Arm Type
Experimental
Arm Description
0.05% atropine eye drop
Arm Title
cross-over
Arm Type
Other
Arm Description
first year: placebo second year: 0.05% atropine eye drop
Intervention Type
Drug
Intervention Name(s)
low concentration atropine (0.01%)
Intervention Description
0.01% atropine eye drop
Intervention Type
Drug
Intervention Name(s)
low concentration atropine (0.025%)
Intervention Description
0.025% atropine eye drop
Intervention Type
Drug
Intervention Name(s)
low concentration atropine (0.05%)
Intervention Description
0.05% atropine eye drop
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drop
Primary Outcome Measure Information:
Title
Proportion of SE changes over -0.75D
Time Frame
2 years
Secondary Outcome Measure Information:
Title
AL change
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age of the screening stage is 3-15 years, both sexes;
One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
Informed consent from the guardian and the child.
Exclusion Criteria:
strabismus, amblyopia or other ocular abnormalities;
The presence of systemic disease abnormalities;
have taken myopia control treatment in the past month;
Allergic to low concentration atropine or sulfuric acid drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haidong Zou
Phone
+86021-53555032
Email
dllcrco@shsyf.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidong Zou
Organizational Affiliation
Shanghai Eye Disease Prevention and Treatment Center
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
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