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A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
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.
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children
Key Details
Gender
All
Age Range
6 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
526
Start Date
2022-05-13
Completion Date
2025-12
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
Lower dose atropine sulfate eye drops
Administer to eyes
Low dose atropine sulfate eye drops
Administer to eyes
placebo
Administer to eyes
Locations (1)
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China