AIM: To investigate the effects of fluorometholone combined with sodium hyaluronate eye drops in the treatment of xerophthalmia and the influence on inflammatory factors in tears.

METHODS: A prospective randomized controlled study was conducted in 116 patients(232 eyes)with xerophthalmia who were treated between February 2017 and December 2019. They were randomly divided into observation group and control group, 58 cases(116 eyes)in each group. The control group was treated with sodium hyaluronate eye drops, while the observation group was treated with 0.1% fluorometholone eye drops based on the treatment for the control group. Ocular Surface Disease Index(OSDI)scoring was carried out before treatment and after 2wk and 4wk of treatment. The tear film break-up time(BUT), Schirmer I test(SⅠt)and corneal fluorescent staining(FL)scores were measured. The tear meniscus height(TMH)and noninvasive keratograph tear breakup time(NIKBUT)were determined by eye surface comprehensive analyzer. Conjunctival impression cytology was performed to determine epithelial cell grading score and goblet cell density. Levels of interleukin 1β(IL-1β), interleukin -6(IL-6)and transforming growth factor β1(TGF-β1)in tears were determined. Meanwhile, efficacy and safety were evaluated.

RESULTS: The overall response rates of the observation group and the control group were 94.8% and 82.8%(P<0.05). The observation group had higher SⅠt, BUT and NIKBUT, lower FL scores and OSDI scores than the control group at 4wk(P<0.05). The goblet cell density was higher in the observation group than in the control group at 4wk(P<0.05). IL-6 and IL-1β in the observation group were significantly lower than those in the control group at 2wk and 4wk, and TGF-β1 was significantly higher than that in the control group at 4wk(P<0.05). The incidences of adverse reactions in the two groups were 3.4% and 1.7%(P>0.05).

CONCLUSION: Fluorometholone combined with sodium hyaluronate can significantly improve clinical symptoms as well as tear film stability in patients with xerophthalmia, which may be related to regulating effect on ocular surface inflammatory factors.