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A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops - Trial NCT06209281

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.

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NCT06209281
Phase 3
Recruitment Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06209281
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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

Study Focus

Myopia

Lower dose atropine sulfate eye drops

Interventional

drug

Sponsor & Location

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Shanghai, China

Timeline & Enrollment

Phase 3

May 13, 2022

Aug 01, 2024

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

Myopia
Degenerative myopia
Amblyopia ex anopsia
Ocular myiasis
Myiasis

Data Source

ClinicalTrials.gov

NCT06209281

Non-Device Trial