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

Sponsor

Shanghai Eye Disease Prevention and Treatment Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05597163

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other), Peking University People's Hospital (Other), Shandong University of Traditional Chinese Medicine (Other)

588

Enrollment

Arms

33.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia, Progressive	Drug: low concentration atropine (0.01%) Drug: low concentration atropine (0.025%) Drug: low concentration atropine (0.05%) Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

588 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.01% atropine 0.01% atropine eye drop	Drug: low concentration atropine (0.01%) 0.01% atropine eye drop
Experimental: 0.025% atropine 0.025% atropine eye drop	Drug: low concentration atropine (0.025%) 0.025% atropine eye drop
Experimental: 0.05% atropine 0.05% atropine eye drop	Drug: low concentration atropine (0.05%) 0.05% atropine eye drop
Other: cross-over first year: placebo second year: 0.05% atropine eye drop	Drug: low concentration atropine (0.05%) 0.05% atropine eye drop Drug: Placebo Placebo eye drop

Outcome Measures

Primary Outcome Measures

Proportion of SE changes over -0.75D [2 years]

Secondary Outcome Measures

AL change [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Study Director: Haidong Zou, Shanghai Eye Disease Prevention and Treatment Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Eye Disease Prevention and Treatment Center

ClinicalTrials.gov Identifier:

NCT05597163

Other Study ID Numbers:

kjb-atp-v1.1-20220825

First Posted:

Oct 27, 2022

Last Update Posted:

Jan 11, 2023

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myopia

Myopia, Degenerative

Atropine

Study Results

No Results Posted as of Jan 11, 2023