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

• DOI: 10.3760/cma.j.issn.2095-0160.2015.09.015
• Publication Date: 2015-09-10
• Authors: Jingyao Chen; Lixin Xie; Zuguo Liu; Hongsheng Bi; Wei Chen; Sanyou Dai; Yingping Deng; Pei Fu; Yangshun Gu; Jing Hong; Yifei Huang; Hui Jia; Li Jiang; Bing Li; Lin Li; Mingshun Li; Rongfeng Liao; Shiqi Ling; Dachuan Liu; Fangyi Liu; Hanqiang Liu; Hong Liu; Zhirong Liu; Ziyan Liu; Lin Ma; Hongren Qin; Junbo Rong; Yunliang Shao; Yuhua Shen; Majing Si; Guanfang Su; Hong Sun; Song Sun; Xu-guang Sun; Hailin Wang; Jie Wang; Liya Wang; Linnong Wang; Jie Wu; Qun Wu; Hanping Xie; Like Xie; Weihua Xu; Xiaoming Yan; Yanning Yang; Xiaoming Yao; Juan Ye; Jin Yuan; Hong Zhang; Lijun Zhang; Liqiong Zhang; Mingchang Zhang; Yuhuan Zhang; Guiqiu Zhao; Shaozhen Zhao; Jinhua Zheng; Hong-jian Zhou; Yongwei Zhu; Yuzhong Zhu
• Keywords: Sodium hyaluronate

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

Objective This aimed to evaluate clinic efficacy pranoprofen eye drops for eye.

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

Results The demography matched groups (both at P>0. 05). 76±0. 66 35±0. 54 14 days 28 after which lower than 1. 41±0. before (t=24. 439, 37. 236, both P=0. 000); those 84±0. 65 45±0. 60 treatment, significant reduce comparison (1. 62) (t=19. 702, 29. 517, 000). score significantly (t=8. 384, 004). BUT delayed (4. 88±2. 40)seconds (6. 03±3. 25) seconds versus (3. 47±2. 10) (t=-13. 358, -17. 734, 000), so ([4. 62±2. 21] [5. 42±2. 70] [3. 50±1. 52] [t=-13. 984, t=-17. 879, 000]). longer (t=10. 483, 001). In addition, symptom, post-treated (all P 05).

Conclusions Pranoprofen has a better effect eye. can relieve symptoms signs very well, especially mild moderate patients.

Key words: Dry eye; Non-steroidal drugs; Pranoprofen; Inflammation