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 < 0.001) and 19.5 for ASED 100% (p < 0.001). Mean improvement in SICCA OSS was 0.96 for PFAT (p = 0.002), 1.63 for ASED 20% (p < 0.001) and 1.95 for ASED 100% (p < 0.001). No significant differences between treatments were found for all other secondary outcomes. Cultures were positive in more than half of the PFAT and ASED vials, with the majority containing commensal flora. Analysis of tear cytokines suggested that ASED promotes a less inflammatory ocular environment than PFAT.

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.