目的：结合医院小儿眼科常见病种调研国内儿童眼用制剂药物临床试验开展现状，为儿童眼用制剂药物临床试验的发展提供参考。方法：基于国家药物临床试验登记与信息公示平台和医院信息系统，结合郑州市第二人民医院儿童眼科病种，分析儿童眼科药物临床试验开展情况。 结果：医院门诊就诊患者以屈光不正最多（占68.49% ），其次是结膜炎（占11.25%），再次是斜视（占8.60%）。平台共检索到相关临床试验165项，儿科专用药物临床试验25项，其中延缓青少年近视方面试验24个，小儿结膜炎试验1个，其他病种药物临床试验检测结果为0；药物临床试验中以I期和Ⅲ期临床试验为主；延缓青少年近视方面试验已完成试验8项，其他都在进行中。结论：儿童眼科疾病的药物治疗尚有巨大的临床需求未满足，直接关系到了儿童健康权益保障与生命安全维护。当前国内儿童眼用制剂研发呈现企业参与度低、创新动力不足的现状，其核心制约因素在于项目少、难度大、涉及更多的伦理问题。建议通过政产学研协同创新，系统性推进儿童眼用制剂的研发进展，切实解决我国儿童眼病治疗用药难的问题，为儿童视觉健康提供有力保障。

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 insufficient innovation motivation. The core constraints are fewer projects, greater difficulty, 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 difficult medication for children 's eye diseases in China and provide a strong guarantee for children 's visual health.

目的：宏观了解2015—2020年中国眼科药物临床试验情况，为我国眼科药物的研发和临床研究提供最新数据参考，为相关决策提供依据。方法：自国家药品监督管理总局药物临床试验登记与信息公示平台登记数据库提取2015—2020年登记的眼科药物临床试验和相关试验药物信息，汇总分析眼科药物临床试验数量、试验分期、试验范围、适应证、药物类型等。结果：2015年1月1日至2020年12月31日共登记98项眼科临床试验。统计每年眼科药物临床试验登记数量，2020年登记的数量最多(28项，占28.57%)；申办方类型中，国内制药企业(75项，占76.53%)发起的眼科药物临床试验数量远高于外资制药企业(23项，占23.47%)；试验分期中，I期临床试验最多(35项，占35.71%)，III期次之(30项，占30.61%)；药物类型中，生物制品数量最多(55项，占56.12%)，化学药物次之(36项，占36.73%)。结论：近6年来，我国眼科药物临床试验进入蓬勃发展时期，尤其是眼底科领域，近2年发展迅速。在创新药领域，国内制药企业已成为眼科新药研发的中坚力量。但创新药大部分集中在眼底科领域，在青光眼、干眼等领域仍需要继续创新。

Objective: To get a macro understanding of the clinical trials of ophthalmic drugs in China from 2015 to 2020, provide the latest data reference for development of ophthalmic drugs and clinical research in China, and provide the basis for relevant decision-making. Methods: The number of clinical trials and related investigational products from 2015 to 2020 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies. Characteristics on number, stage, scope, indications, type were summarized and depicted. Results: There were 98 ophthalmic clinical trials registered in China from January 1, 2015 and December 31, 2020. The year of 2020 hit the highest record of registered ophthalmic clinical trials for 28, accounting for 28.57%. Among sponsor, 75 (accounting for 76.53%) were initiated by domestic pharmaceutical enterprises, much higher than initiated by foreign pharmaceutical enterprises (23, accounting for 23.47%). Among stage, the quantity of phase I (35, accounting for 35.71%) was the largest, followed by phase III (30, accounting for 30.61%). Among type, the quantity of biological product was the largest (55, accounting for 56.12%), followed by chemical product (36, accounting for 36.73%). Conclusion: The past 6 years have seen vigorous growth of ophthalmic clinical trials, particularly in the last 2 years in the field of fundus. Domestic pharmaceutical enterprises have become the central pillar of ophthalmic drugs renovation. However, their focus is limited to fundus, innovation is still needed in areas such as glaucoma xerophthalmia.