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NCT06209281

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

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
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.·Phase 3·ClinicalTrials.gov·drugRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Myopia
Drug/Device/Intervention
Lower dose atropine sulfate eye drops
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 3
Start date
May 13, 2022
End date
Aug 01, 2024
Enrollment
526 participants
Primary outcome

Cycloplegic Autorefraction(low)

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.

ICD-10 classifications
MyopiaDegenerative myopiaAmblyopia ex anopsiaOcular myiasisMyiasis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06209281
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06209281 through Pure Global AI's free database. This Phase 3 trial is sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. and is currently Recruitment Completed. The study focuses on Myopia. Target enrollment is 526 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.