Analysis of the current situation of clinical trials of ophthalmic drugs in children based on the common diseases of pediatric ophthalmology in hospital

[Objective:] Combined with the common diseases of pediatric ophthalmology in our hospital, the current situation of clinical trials of ophthalmic preparations for children in China was investigated to provide reference for the development of clinical trials of ophthalmic preparations for children in China. [Methods:] Based on the national drug clinical trial registration and information publicity platform and hospital information system, combined with the pediatric ophthalmic diseases in our hospital, the development of pediatric ophthalmic drug clinical trials was analyzed. [Results:] Among the outpatients in our hospital, ametropia was the most common ( 68.49 % ), followed by conjunctivitis ( 11.25 %)and strabismus ( 8.60 % ). A total of 165 clinical trials and 25 clinical trials of pediatric drugs were retrieved from the platform, including 24 trials on delaying juvenile myopia, 1 trial on pediatric conjunctivitis, and 0 clinical trial on other diseases. Drug clinical trials were mainly phase I and phase III clinical trials. Eight trials have been completed to delay juvenile myopia, and others are in progress. [Conclusions:] There is still a huge clinical demand for the drug treatment of children 's eye diseases, which is directly related to the protection of children 's health rights and life safety. At present, the research and development of children 's ophthalmic preparations in China presents the current situation of low enterprise participation and insuf fi cient innovation motivation. The core constraints are fewer projects, greater dif fi culty, and more ethical issues. It is suggested to systematically promote the research and development of ophthalmic preparations for children through the collaborative innovation of government, industry, university and research, so as to effectively solve the problem of dif fi cult medication for children 's eye diseases in China and provide a strong guarantee for children 's visual health