Efficacy and safety of topical cyclosporine 0.1% eye drops in the treatment of dry eye disease in patients with rheumatoid arthritis

Context The most prevalent ocular symptom of rheumatoid arthritis (RA) is dry eye disease (DED), especially keratoconjunctivitis sicca, which has a major negative impact on patients’ quality of life. Immunomodulatory drugs such as topical cyclosporine A (CsA) target the chronic inflammation that is a part of DED etiology. Aims To evaluate the efficacy of 0.1% CsA eye drops in conjunction with artificial tear eye drops for the treatment of DED in RA patients. Patients and methods A total of 60 RA patients who met the ACR-EULAR 2010 criteria were included in this prospective, randomized, controlled, interventional clinical study. For a month, patients were randomly assigned to either the Study group (topical CsA 0.1%+artificial tears, n =30) or the Control group (artificial tears alone, n =30). Results At 1 month, all primary endpoints showed substantially better results for the Study group than for the Control group ( P <0.0054). Specifically, in the Study group, 23.3% of patients achieved a Normal Ocular Surface Disease Index score versus 0% in the Control group, and 80.0% achieved Normal TBUT versus 10.0% in the Control group ( P <0.001). Additionally, the study group’s Oxford staining grade showed a significant improvement ( P <0.001). Burning or stinging was the sole significant adverse event, occurring in 6.7% of the study group ( P =0.039). Conclusions In RA-associated DED, topical CsA 0.1% eye drops dramatically improve tear film stability, ocular surface integrity, and patient-reported symptoms in a safe and effective manner.