The Therapeutic Efficacy of Jīn Zhēn Eye Drop in Treating Dry Eye in a Chinese Population: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Methods: In this phase IV, randomized, double-blind, placebo-controlled trial, participants with DED were randomly assigned to receive either Jīn Zhēn eye drops or placebo (0.9% saline solution) for 28 days. The primary endpoint was the change in corneal fluorescein staining score (tCFS) and eye dryness score (EDS), and secondary endpoints included ocular surface disease index (OSDI) scores, Visual Analogue Scale (VAS) scores, fluorescein break-up time (FBUT), Schirmer’s I test (SIT), and safety evaluations.

Findings: In this study, totally 250 patients were randomized, and finally 236 patients completed the follow-up, with each group retaining 118 individuals. The trial group exhibited significant improvements in EDS and tCFS scores (32.78± 1.86 vs 54.67 ± 22.29, p<0.0005;2.79 ± 0.19 vs 4.17± 2.31, p<0.0005), and after treatment, the differences in EDS and tCFS scores from baseline were greater than those in the control group (-21.89±1.538 vs -8.94±1.581, P<0.001; -1.377±0.218 vs -0.068±0.236, P<0.001). The overall safety profile of Jīn Zhēn eye drop was good, with ocular TEAEs occurring in 7 individuals (5.6%) in the trial group and 4 individuals (3.2%) in the control group (p<0.05).

Interpretation: Using Jīn Zhēn eye drops for 28 days significantly improves both the symptoms and signs of dry eye, with a good safety profile, presenting a promising alternative for managing DED.

Trial Registration: This study is an interventional Clinical Trial, which has been registered in the Chinese Clinical Trial Registry (ChiCTR), and has obtained the clinical trial registration number: ChiCTR2300071953

Funding: Hefei Lifeon Pharmaceutical Co. Ltd.

Declaration of Interest: The authors declare that there is no conflict of interest regarding the publication of this paper.

Ethical Approval: Informed consent was obtained from all participants before enrollment. The study was conducted in accordance with the aims of the Declaration of Helsinki. The study involving human participants was reviewed and approved by the Ethics Committee of Beijing Tongren Hospital (board approval number: TREC2022-118). The patients/participants provided their written informed consent to participate in this study.