Evaluation of the Efficacy and Safety of Topical 0.05% Cyclosporine Eye Drops (II) in the Treatment of Dry Eye Associated with Primary Sjögren's Syndrome.

PURPOSE: To evaluate the efficacy and safety of 0.05% cyclosporine eye drops (II) for the treatment of primary Sjögren's syndrome-associated dry eye (PSSDE). METHODS: Sixty patients with PSSDE were randomly divided into three groups, received treatment with 0.05% cyclosporine (C group), artificial tears (S group) or their combination (CS group). The evaluation indicators were evaluated at baseline and at weeks 2, 4 and 12. RESULTS: The symptoms of C and CS groups were reduced significantly. The signs [schirmer I test (F = 4.838, p = .011), ocular staining score (F = 7.961, p = .001) and tear break-up time (F = 9.283, p < .001)] were significantly different between S and C groups as well as S and CS groups. The tear meniscus height (F = 3.197, p = .048) was significantly different between S and CS groups. No serious adverse events occurred. CONCLUSION: 0.05% cyclosporine is an effective and safe treatment for patients with PSSDE.