Zhangyanming Tablets for Dry Eye Disease: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study

WU Hu-ping; GU Jian-jun; FANG Jie; ZHAO Dong-qing; SUN Sheng-tao; LUO Shun-rong; LIN Zhi-rong; HU Jia-jia

doi:10.1007/s11655-026-4050-y

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Zhangyanming Tablets for Dry Eye Disease: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study

Original Article | Updated：2026-11-13

- Zhangyanming Tablets for Dry Eye Disease: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study
- Chinese Journal of Integrative Medicine Vol. 32, Issue 11, Pages: 963-971(2026)
- Affiliations：
  
  Xiamen Eye Center of Xiamen University, Fujian Provincial Key Laboratory of Ocular Surface and Corneal Diseases, Xiamen, Fujian Province (361002), China
  Department of Corneal Diseases, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (510060), China
  Cornea and Ocular Surface Disease Center, Henan Eye Hospital, Henan Provincial People's Hospital, Zhengzhou (450003), China
  State Key Laboratory of Eye Health, Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang Province (325027), China
- Author bio：
  
  Correspondence to: Dr. WU Hu-ping, E-mail: wuhuping123@163.com
- Funds：
- DOI：10.1007/s11655-026-4050-y
  CLC：
- Accepted：01 April 2026，
  
  Published：2026-11
- Accepted：
Scan QR Code
WU Hu-ping, GU Jian-jun, FANG Jie, et al. Zhangyanming Tablets for Dry Eye Disease: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study[J]. Chinese Journal of Integrative Medicine, 2026, 32(11): 963-971.
DOI：

WU Hu-ping, GU Jian-jun, FANG Jie, et al. Zhangyanming Tablets for Dry Eye Disease: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study[J]. Chinese Journal of Integrative Medicine, 2026, 32(11): 963-971. DOI： 10.1007/s11655-026-4050-y.

摘要

Abstract

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)

关键词

Keywords

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