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

NCT05597163 | Unknown

• 1 other identifier: kjb-atp-v1.1-20220825
• Study Type: interventional
• Target: 588
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

• Proportion of SE changes over -0.75D

  2 years

Secondary Outcomes (1)

• AL change

  2 years

Study Arms (4)

0.01% atropine

EXPERIMENTAL

0.01% atropine eye drop

Drug: low concentration atropine (0.01%)

0.025% atropine

EXPERIMENTAL

0.025% atropine eye drop

Drug: low concentration atropine (0.025%)

0.05% atropine

EXPERIMENTAL

0.05% atropine eye drop

Drug: low concentration atropine (0.05%)

cross-over

OTHER

first year: placebo second year: 0.05% atropine eye drop

Drug: low concentration atropine (0.05%); Drug: Placebo

Interventions

low concentration atropine (0.01%) DRUG

0.01% atropine eye drop

0.01% atropine

low concentration atropine (0.025%) DRUG

0.025% atropine eye drop

0.025% atropine

low concentration atropine (0.05%) DRUG

0.05% atropine eye drop

0.05% atropine; cross-over

Placebo DRUG

Placebo eye drop

cross-over

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Haidong Zou

  Shanghai Eye Disease Prevention and Treatment Center

  STUDY DIRECTOR

Central Study Contacts

Haidong Zou

CONTACT

+86021-53555032; dllcrco@shsyf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: January 15, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: January 11, 2023

Record last verified: 2022-10