Efficacy and safety of 20% and 100% autologous serum eye drops in patients with severe dry eye disease: a prospective, blinded, randomized, crossover study

Purpose To evaluate the efficacy and safety of 20% and 100% autologous serum eye drops (ASED), compared to preservative-free artificial tears (PFAT), as a treatment for severe dry eye disease (DED).Methods Forty-six patients with severe DED were randomized to receive PFAT, ASED 20% and ASED 100% for 8 weeks in a crossover study design with a 2-week washout period. The Ocular Surface Disease Index (OSDI) questionnaire was used as primary outcome measure. Secondary outcomes were non-invasive tear break-up time (tBUT), best-corrected visual acuity, Schirmer 1 test, ocular surface staining (OSS) using the Sjögren's International Collaborative Clinical Alliance (SICCA) OSS score, tBUT, conjunctival injection score and Meibomian gland dysfunction grading. Additionally, serum and tear cytokine analysis and microbiological cultures were performed.Results Mean improvement in OSDI-score compared to baseline was 3.0 for PFAT (p = 0.35), 12.3 for ASED 20% (p Conclusions ASED 100% provided the greatest improvement in OSDI and SICCA OSS scores compared to baseline, supporting the clinical value of higher concentrations of autologous serum.