Overview

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

Status:
RECRUITING

Trial end date:
2027-12-31

Target enrollment:

Participant gender:

Summary

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.

Phase:

PHASE3

Details

Lead Sponsor:

Oupushifang Pharmaceutical Technology Co., Ltd.

Collaborators:

AUTEK China Inc.
Seefunge Pharmaceutical Technology Co., Ltd.