Li, Suxia
Xu, Jianjiang
Yuan, Jin
Pan, Zhiqiang
Siri, Giacomo
Hauswirth, Scott G.
Mantelli, Flavio
Shi, Weiyun
Funding for this research was provided by:
Dompé farmaceutici S.p.A.
Article History
Received: 4 August 2025
Accepted: 16 September 2025
First Online: 5 October 2025
Declarations
:
: Giacomo Siri, Scott G. Hauswirth, and Flavio Mantelli are employees of Dompé farmaceutici S.p.A. Suxia Li, Jianjiang Xu, Jin Yuan, Zhiqiang Pan, and Weiyun Shi have nothing to disclose.
: This study was conducted in accordance with the International Conference on Harmonisation (ICH) and National Medical Products Administration (NMPA) Good Clinical Practice (GCP) guidelines; all applicable national laws, guidelines, and Independent Ethics Committee (IEC) regulations; the Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the International Society for Pharmacoepidemiology (ISPE); and the Declaration of Helsinki (and its amendments). In addition, the investigators obtained protocol approval from all properly constituted IECs prior to initiating the study, and all patients provided written informed consent before study screening. Each site had a separate ethics committee: Clinical Trial Ethics Committee of Eye hospital of Shandong First Medical University; Medical Ethics Committee of Zhongshan Ophthalmology Center, Sun Yat-sen University; Ethics Committee of Eye, Ear, Nose, and Throat Hospital of Fudan University; and Ethics Committee of Beijing Tongren Hospital, Capital Medical University.