Cyclosporine A in the treatment of dry eye syndrome in patients with Sjögren’s disease—a systematic review

<h2>ABSTRACT</h2><h3>Objectives</h3> The objective of this study is to systematically evaluate the efficacy and safety of cyclosporine A (CsA) in treating dry eye syndrome (DES) among patients with Sjögren's disease (SjD). <h3>Methods</h3> A systematic search was conducted in PubMed, Cochrane, Embase, CINAHL, and Web of Science on January 30, 2025, for randomised controlled trials (RCTs) assessing CsA for SjD-related DES. Studies were included if they evaluated CsA in any concentration, formulation, or mode against placebo or vehicle controls and reported at least 1 of the following: Schirmer test, tear breakup time (TBUT), Rose Bengal staining score, Ocular Surface Disease Index (OSDI), or adverse events. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. <h3>Results</h3> Four RCTs met inclusion criteria. Three of them investigated topical formulations (0.05%-2.0%), while 1 studied oral CsA. Topical CsA was associated with significant improvements in TBUT, Rose Bengal staining, and OSDI scores compared with controls. Schirmer test results were mixed, with 2 of 3 topical CsA studies showing significant improvement. Oral CsA showed no significant benefit in Schirmer test. Adverse effects were mild and consistent with known profiles, with systemic side effects occurring only in the oral CsA study. Two studies had high risk of bias, and 2 had some concerns. <h3>Conclusions</h3> Topical CsA appears effective and well-tolerated for treating DES in SjD, particularly in improving tear film stability and ocular surface integrity. Oral CsA remains of uncertain benefit. Further large-scale, high-quality RCTs are warranted.