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A one-year clinical trial of Xingqi eye atropine sulfate eye drops to delay the progression of myopia in children obtained a phase III. clinical trial summary report

 Last Update: 2022-12-30
 Source: Internet
 Author: User

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Shenyang Xingqi Eye Medicine Co.
, Ltd.
(hereinafter referred to as the "Company") signed a cooperation agreement with the National Eye Centre of Singapore (SNEC) in June 2016, and on the basis of SNEC's exclusively authorized domestic atropine sulfate eye drops prescription and 5-year clinical trial data, the company carried out the phase III clinical trial
of atropine sulfate eye drops.
Recently, the company completed a "randomized, double-blind, placebo-controlled, multicenter 1-year clinical trial of the efficacy and safety of atropine sulfate eye drops in delaying myopia progression in children"
.
After data management and statistical analysis, the summary report
of phase III.
clinical trial of atropine sulfate eye drops for 1 year has been obtained.

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial in which 406 pediatric subjects aged 6 to 12 years underwent 1-year medication observation and 0.
5 years follow-up observation after discontinuation to evaluate the efficacy and safety
of atropine sulfate eye drops in delaying myopia progression in children.
The results showed that the atropine sulfate eye drop group had a statistically significant difference in the main efficacy indicators compared with the placebo group, and the atropine sulfate eye drop group was better than the placebo group, with good safety and good patient compliance
.

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