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Clinical Trials in China / NCT06209281
Active, not recruiting Phase 3

A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops

NCT06209281 · tracked via the Priya Life Science China tracker
Sponsor
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Phase
Phase 3
Started
2022-05-13
Last updated
2025-07-30

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

Lower dose atropine sulfate eye dropsLow dose atropine sulfate eye dropsplacebo

Lower dose atropine sulfate eye drops: Administer to eyes

Low dose atropine sulfate eye drops: Administer to eyes

placebo: Administer to eyes

Study summary

This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.

Eligibility

Sex
ALL
Min age
6 Years
Max age
10 Years
Healthy volunteers
No
Inclusion Criteria: 1. Child (female or male) aged 6 to 10 years. 2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by cycloplegic autorefraction. 3. If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction. 4. Anisometropia SER of \< 1.50 D as measured by cycloplegic autorefraction. Exclusion Criteria: 1. History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity). 2. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia). 3. Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year). Use of cycloplegic drops for dilated ocular exam was allowable. 4. Heart rate persistently (for more than 10 minutes) \> 120 beats per minute. 5. Allergy to study drugs.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Eye & ENT Hospital of Fudan University Shanghai Shanghai Municipality

More Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06209281 on ClinicalTrials.gov ↗ ← All trials in China