A randomized, double-blind, placebo-controlled pre-trial study of SYMBLYOPIA (Levodopa Tablets) for the treatment of amblyopia in children

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000030023

Enrollment

Unknown

Registered

2020-02-20

Start date

2020-03-10

Completion date

Unknown

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ametropic amblyopia, anisometropic amblyopia or strabismic amblyopia

Interventions

experimental groups:SYMBLYOPIA (Levodopa Tablets) +Occlusion therapy

control group:Placebo+Occlusion therapy

Eligibility

Sex/Gender

All

Age

5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged five to twelve years old. Male or female. 2. People without organic diseases of eyes (except strabismus). 3. Diagnosed as ametropic amblyopia, anisometropic amblyopia and strabismus amblyopia. 4. Sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with serious endocrine diseases, and diseases of bronchia, lung, liver, kidney and cardiovascular. 2. Patients with amblyopia treated with methods other than comprehensive therapy (CAM optometric stimulator, heidinger's brush, red flash, suppression, after image and fine visual work at home); 3. Non-compliant patient. 4. Patients with contraindications to levodopa (severe mental illness, severe arrhythmia, heart failure, glaucoma, gastrointestinal ulcers, and a history of convulsions). 5. Patients with a history of levodopa or physical therapy in the first three months.

Design outcomes

Primary

Measure	Time frame
vision;	—

Secondary

Measure	Time frame
P-VEP (pattern visual evoked potential);Visual contrast sensitivity;stereopsis;	—

Countries

China

Contacts

Public ContactLi Li

liliyk1@163.com+86 13911696086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026