Comparison of 0.05% cyclosporine A and 25% autologous serum in treating severe dry eye disease: a retrospective comparative study

Abstract Background Dry eye disease (DED) is a multifactorial ocular surface disorder marked by tear film instability and ocular surface inflammation, and ranks among the most prevalent conditions compromising vision and quality of life, second only to refractive errors. Common manifestations include ocular burning, persistent dryness, foreign body sensation, pain, asthenopia, and reduced visual acuity. Methods This retrospective comparative study compared the therapeutic efficacy of 0.05% cyclosporine A ophthalmic emulsion (COE) with 25% autologous serum (AS) in patients with severe DED. Electronic medical records from July 2022 to July 2024 were screened, identifying 52 patients with severe DED; after complete-case selection and frequency matching on sex and 5-year age bands, the final analytic cohort comprised 80 eyes of 40 patients (24 women, 16 men), classified according to the treatment received in routine clinical care: Group AS received 25% autologous serum eight times daily, and Group COE received 0.05% cyclosporine A emulsion twice daily, each for 3 months. Both groups also received non-preserved artificial tears four times daily. The Ocular Surface Disease Index (OSDI), Schirmer test, and tear break-up time (TBUT) were assessed before treatment and at 1, 2, and 3 months, and the results were statistically analyzed. Results No significant inter-group differences were found in age ( p = 0.52) or sex distribution ( p = 1.00). OSDI improved in both groups, with Group AS showing marginally greater symptomatic gains, but inter-group differences were not significant at any time point ( p = 0.06, 0.65, 0.51). Both groups achieved significant gains in TBUT and Schirmer scores across the 3-month follow-up ( p < 0.001 for both); although improvements were marginally larger in Group COE, between-group differences were not significant (Schirmer: p = 0.37, 0.43, 0.49; TBUT: p = 0.52, 0.69, 0.34). Conclusions Both 0.05% cyclosporine A and 25% autologous serum produced significant within-group improvements in TBUT and Schirmer scores over 3 months in severe DED, with no significant between-group differences. OSDI changes were modest and not statistically significant in either group, suggesting that objective tear-film measures were more responsive than symptom scoring during the short 3-month follow-up period.