Clinical effect of pranoprofen eye drops for mild and moderate dry eye–a multicenter, randomized, controlled clinical trial

Authors: Chen Jingyao,  Xie Lixin,  Liu Zuguo,  Bi Hongsheng,  Chen Wei,  Dai Sanyou,  Deng Yingping,  Fu Pei,  Gu Yangshun,  Hong Jing,  Huang Yifei,  Jia Hui,  Jiang Li,  Li Bing,  Li Lin,  Li Mingshun,  Liao Rongfeng,  Ling Shiqi,  Liu Dachuan,  Liu Fangyi,  Liu Hanqiang,  Liu Hong,  Liu Zhirong,  Liu Ziyan,  Ma Lin,  Qin Hongren,  Rong Junbo,  Shao Yunliang,  Shen Yuhua,  Si Majing,  Su Guanfang,  Sun Hong,  Sun Song,  Sun Xuguang,  Wang Hailin,  Wang Jie,  Wang Liya,  Wang Linnong,  Wu Jie,  Wu Qun,  Xie Hanping,  Xie Like,  Xu Weihua,  Yan Xiaoming,  Yang Yanning,  Yao Xiaoming,  Ye Juan,  Yuan Jin,  Zhang Hong,  Zhang Lijun,  Zhang Liqiong,  Zhang Mingchang,  Zhang Yuhuan,  Zhao Guiqiu,  Zhao Shaozhen,  Zheng Jinhua,  Zhou Hongjian,  Zhu Yongwei,  Zhu Yuzhong,  Tao Linglong
DOI: 10.3760/cma.j.issn.2095-0160.2015.09.015
Published 2015-09-10
Cite as Chin J Exp Ophthalmol, 2015,33(9): 834-839.

Abstract                              [Download PDF] [Read Full Text]

Background

Nonsteroidal anti-inflammatory drugs are widely used in the treatment of dry eye, but the related multicenter clinical study is lack.

Objective

This study aimed to evaluate the clinic efficacy of pranoprofen eye drops for dry eye.

Methods

This study protocol followed the Declaration of Helsinki, and oral informed consent was obtained from each patient prior to entering the cohort. A randomized, open, parallel, controlled, multi-center clinical trial was conducted. Total 1 023 patients with dry eye were enrolled based on the same diagnosis criteria in 58 eye institutes of China from July 2011 to July 2012. The patients was randomized into trial group and control group. The combination of 0. 1% pranoprofe dry drops (4 times per day) with 0. 1% sodium hyaluronate eye drops (4 times per day) was used in the trial group, and only 0. 1% sodium hyaluronate eye drops was used in the same way in the control group. The primary evaluated indexes included corneal fluorescence staining scores and break-up time of tear film (BUT), and secondary outcome measurements were the dry eye symptom scores and palpebral conjunctiva congestion and papilla scores as well as Shirmer Ⅰ test (SⅠt). The best corrected visual acuity (BCVA) and adverse response were compared between the two groups.

Results

The demography was matched between the two groups (both at P>0. 05). The corneal fluorescence staining scores were 0. 76±0. 66 and 0. 35±0. 54 in 14 days and 28 days after treatment in the trial group, which were lower than 1. 41±0. 58 before treatment (t=24. 439, 37. 236, both at P=0. 000); those in the control group were 0. 84±0. 65 and 0. 45±0. 60 in 14 and 28 days after treatment, with significant reduce in comparison with before treatment (1. 41±0. 62) (t=19. 702, 29. 517, both at P=0. 000). The corneal fluorescence staining score was significantly lower in the trial group compared with the control group in 28 days after treatment (t=8. 384, P=0. 004). The BUT was significantly delayed in 14 and 28 days after treatment compared with before treatment in the trial group (4. 88±2. 40)seconds and (6. 03±3. 25) seconds versus (3. 47±2. 10) seconds (t=-13. 358, -17. 734, both at P=0. 000), and so were the control group ([4. 62±2. 21] seconds and [5. 42±2. 70] seconds versus [3. 50±1. 52] seconds [t=-13. 984, t=-17. 879, both at P=0. 000]). The BUT was longer in the trial group compared with the control group in 28 days after treatment (t=10. 483, P=0. 001). In addition, the scores of dry eye symptom, palpebral conjunctiva congestion and papilla were significantly lower in the trial group than those in the control group in post-treated 14 and 28 days (all at P<0. 05). SⅠt was remarkably elevated and BCVA was considerably improved in the trial group compared with the control group in 28 days (t=9. 732, P=0. 002; t=-3. 687, P=0. 000). No significant difference was seen in the number of eyes with adverse response between the two groups (P>0. 05).

Conclusions

Pranoprofen has a better anti-inflammatory effect on dry eye. The combination of 0. 1% pranoprofe dry drops with 0. 1% sodium hyaluronate eye drops can relieve dry eye symptoms and signs very well, especially in mild and moderate dry eye patients.

Key words:

Dry eye; Non-steroidal anti-inflammatory drugs; Pranoprofen; Inflammation

Contributor Information

Chen Jingyao
Eye Institute of Xiamen University & Xiamen Eye Center of Xiamen University, Xiamen 361001, China
Xie Lixin
Liu Zuguo
Bi Hongsheng
Chen Wei
Dai Sanyou
Deng Yingping
Fu Pei
Gu Yangshun
Hong Jing
Huang Yifei
Jia Hui
Jiang Li
Li Bing
Li Lin
Li Mingshun
Liao Rongfeng
Ling Shiqi
Liu Dachuan
Liu Fangyi
Liu Hanqiang
Liu Hong
Liu Zhirong
Liu Ziyan
Ma Lin
Qin Hongren
Rong Junbo
Shao Yunliang
Shen Yuhua
Si Majing
Su Guanfang
Sun Hong
Sun Song
Sun Xuguang
Wang Hailin
Wang Jie
Wang Liya
Wang Linnong
Wu Jie
Wu Qun
Xie Hanping
Xie Like
Xu Weihua
Yan Xiaoming
Yang Yanning
Yao Xiaoming
Ye Juan
Yuan Jin
Zhang Hong
Zhang Lijun
Zhang Liqiong
Zhang Mingchang
Zhang Yuhuan
Zhao Guiqiu
Zhao Shaozhen
Zheng Jinhua
Zhou Hongjian
Zhu Yongwei
Zhu Yuzhong
Tao Linglong
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