Topical Fluorometholone Treatment for Ocular Dryness in Patients With Sjögren Syndrome: A Randomized Clinical Trial in China

The purpose of the study was to evaluate the efficacy of an ophthalmic solution containing 0.1% fluorometholone (FML) and 0.1% sodium hyaluronate (HA) for the treatment of ocular dryness in Sjögren syndrome (SS) patients. Forty SS patients were randomly assigned to the FML or cyclosporin A (CsA) treatment groups. The FML group was treated with 0.1% FML and 0.1% HA, and the CsA group was treated with 0.5% CsA and 0.1% HA. Primary outcomes were corneal fluorescein staining (CFS), the Ocular Surface Disease Index (OSDI) score, conjunctival goblet cell density, and the severity of conjunctival congestion. Patients were also evaluated based on tear film breakup time (TFBUT) and the Schirmer test. After 8 weeks of treatment, the mean CFS scores were significantly lower in both the groups, compared with the baseline values, and the CFS score of the FML group at week 2 was significantly lower than that of the CsA group (P = 0.042). The OSDI scores improved significantly in both the groups throughout the study, and the OSDI score in the FML group at week 4 was significantly lower than that of the CsA group (P = 0.042). After 8 weeks of therapy, the conjunctival goblet cell density was significantly higher in both the groups (P < 0.001 for both) compared with the baseline values. Conjunctival congestion was reduced in both the groups throughout the study, and the severity in the FML group was significantly less at week 4 compared with that in the CsA group (P = 0.035). The TFBUT in the FML group at week 8 was significantly longer than in the CsA group (P = 0.04). Treatment using topical 0.1% FML provided faster improvement in the symptoms of ocular dryness in SS patients compared with topical 0.5% CsA.