Allogeneic and autologous serum eye drops: a pilot double-blind randomized crossover trial.

Abstract

PURPOSE\nSerum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient s blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood donors does not have these disadvantages. Our aim was to evaluate whether autologous and allogeneic SEDs have comparable efficacy and tolerability.\n\n\nMETHODS\nIn a prospective, double-blind crossover trial, patients with severe dry eyes were randomized to first receive autologous SEDs for one month, followed by one-month washout, before receiving allogeneic SEDs for 1\xa0month; or receive the SED preparations in reverse order. The Ocular Surface Disease Index (OSDI) was the primary endpoint, and various secondary endpoints were determined. A linear mixed model with random intercept for each patient was applied per treatment group to compare the pre- and postoutcome measurements.\n\n\nRESULTS\nNineteen patients were enrolled, of whom 15 completed the trial. When autologous SEDs were used, the mean\xa0±\xa0SD OSDI improved from 62\xa0±\xa019 to 57\xa0±\xa018. For allogeneic SEDs, the OSDI changed from 59\xa0±\xa020 to 56\xa0±\xa023. The estimated mean difference (95% confidence interval) was -4.2 (-9.5 to 1.2) for autologous and -4.5 (-9.8 to 0.9) for allogeneic SEDs (both, not significant). Adverse events were mild and resolved completely.\n\n\nCONCLUSION\nAutologous and allogeneic SEDs have comparable efficacy and tolerability for use in patients with severe dry eyes. Allogeneic SEDs are therefore an attractive alternative for patients who need SEDs but are clinically or logistically unable to donate blood.