Clinical trials

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Condition / disease
Location
Status: Recruiting

The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression

The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents. Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) in delaying myopia progression in children and adolescents. Exploratory Objective: 1. the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks. 2. evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.

Participants needed: 606
Trial details
Phase: Phase 3Age: 6-12Biological sex: AllType: InterventionalSponsor: Oupushifang Pharmaceutical Technology Co., Ltd.Updated: Dec 24, 2024Locations: 25
Eligibility criteria

The legal guardian of the subject voluntarily signed the written informed consen... [+5]

Allergic to this product or its excipients. [+11]