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

Abstract

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). 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