Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

Myopia, Progressive Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05597163
• Other study ID #: kjb-atp-v1.1-20220825
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Haidong Zou
• Phone: +86021-53555032
• Email: dllcrco[@]shsyf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 588
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

1. The age of the screening stage is 3-15 years, both sexes;

2. 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;

3. Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;

4. Informed consent from the guardian and the child.

Exclusion Criteria:

1. strabismus, amblyopia or other ocular abnormalities;

2. The presence of systemic disease abnormalities;

3. have taken myopia control treatment in the past month;

4. Allergic to low concentration atropine or sulfuric acid drugs.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Drug:
• low concentration atropine (0.01%)
0.01% atropine eye drop
• low concentration atropine (0.025%)
0.025% atropine eye drop
• low concentration atropine (0.05%)
0.05% atropine eye drop
• Placebo
Placebo eye drop

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center	Peking University People's Hospital, Shandong University of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of SE changes over -0.75D		2 years
Secondary	AL change		2 years