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Updated: Sep 14, 2026
Establishment of A Mouse Model of Aqueous Deficiency Dry Eye
Published on: November 1, 2024
Zhangyanming Tablets for Dry Eye Disease: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study
Hu-Ping Wu1, Jian-Jun Gu2, Jie Fang3
1Fujian Provincial Key Laboratory of Ocular Surface and Corneal Diseases, Xiamen Eye Center of Xiamen University, Xiamen, Fujian Province, 361002, China. wuhuping123@163.com.
Objective:
To evaluate the efficacy and safety of Zhangyanming Tablets (ZYMT) combined with 0.1% sodium hyaluronate eye drops for dry eye disease (DED).
Methods:
A stratified, randomized, doubleblind, placebo-controlled multicenter trial was conducted from June 2022 to August 2024, enrolling 144 patients with DED from 3 centers. Participants were randomized 1:1 to either the ZYMT group (ZYMT + 0.1% sodium hyaluronate, n=72) or the control group (placebo + 0.1% sodium hyaluronate, n=72). Participants received the study tablets (2 tablets orally, 3 times daily) concurrently with the eye drops (1 drop, 5 times daily) for 8 weeks. The primary outcome was the mean change from baseline in the ocular surface disease index (OSDI) score. The secondary outcomes included the efficacy rate, the mean change from baseline in the tear film breakup time (TFBUT), Schirmer's test, corneal fluorescein staining (CFS) and Chinese medicine (CM) syndrome score. Safety was assessed by monitoring adverse events, vital signs, and laboratory parameters (hematology, urinalysis, liver and kidney functions, and electrocardiogram).
Results:
A total of 119 patients completed this study, among which 58 were in the ZYMT group and 61 were in the control group. After 8 weeks of treatment, the mean change from baseline in the OSDI score in the ZYMT group was significantly greater than those in the control group in week 8 [absolute difference -5.66, 95% confidence interval (CI), -9.56 to -1.76]. The efficacy rate was 62.1% (36/58) in the ZYMT group versus 42.6% (26/61) in the control group (relative risk: 1.46, 95% CI, 1.02 to 2.08). The mean changes from baseline in TFBUT and CM symptom score were significantly greater in the ZYMT group than those in the control group at week 8 (P<0.05). No significant differences were observed between the two groups in Schirmer's test, CFS, or safety data (all P>0.05).
Conclusion:
ZYMT combined with 0.1% sodium hyaluronate eye drops can significantly alleviate the ocular symptoms, improve tear film, and demonstrate a good safety. (Registration No. ChiCTR2200061479).