AIM:To systematically evaluate the efficacy and safety of lifitegrast in the treatment of dry eye disease, and to provide the basis for the selection of drug treatment for dry eye disease.

METHODS: Randomized controlled trials about lifitegrast in the treatment of dry eye disease were searched in CNKI, VIP, CBM, PubMed, Embase and The Cochrane Library databases from inception to March 2019. The collected literatures were strictly screened according to the established inclusion and exclusion criteria, and the Cochrane collaborative network bias risk assessment tool was used to evaluate the quality of the included studies, RevMan 5.3 software was used for meta-analysis of efficacy and safety indicators.

RESULTS: A total of 5 randomized controlled trials that met the inclusion criteria were included in this study, with a total sample size of 2 465 participants. According to the result of Meta-analysis: compared with placebo, after 84d of treatment, the score of corneal staining(CSS)\〖MD= -0.17, 95% CI (-0.29, -0.05), P=0.006\〗, the score of eye dryness(EDS)\〖MD= -7.95, 95% CI (-11.96, -3.93), P=0.0001\〗, all the differences were statistically significant. It showed that lifitegrast eye drops had better effect than placebo in the treatment of dry eye disease. In terms of safety, the incidence of severe adverse reactions \〖OR=0.95, 95% CI (0.50, 1.81), P=0.88\〗; in terms of common adverse reactions, the incidence of adverse reactions such as instillation site irritation, instillation site reaction and dysgeusia were higher than that of placebo(P<0.05).

CONCLUSION: Lifitegrast is effective and safe in the treatment of dry eye disease.