Randomized controlled study: Comparison of 20% autologous- serum eye drops with unpreserved hypromellose in the treatment of aqueous-tear- deficient dry-eye disease

Abstract

Objective: This study evaluated the effectiveness of 20% autologous-serum eye drops versus unpreserved hypromellose in the treatment of patients with aqueoustear-deficient dry-eye disease.

Methods: Patients fulfilling entry criteria were randomized to either 8 weeks of 20% autologous serum eye drops or 8 weeks of unpreserved hypromellose eyedrops. Changes from baseline at 1, 2, 4, and 8-week values of corneal and conjunctival staining with fluorescein and lissamine green, tear-break-up time (TBUT), Schirmer test (with anesthesia), and ocular-surface-disease index (OSDI) were measured. Statistical analyses were carried out using analysis of variance (ANOVA) and the Bonferroni-Holm adjustment.

Results: Thirty eyes (15 patients) in the autologous-serum group and 26 eyes (13 patients) in the unpreserved-hypromellose group completed the study. Corneal staining with lissamine green (p = 0.05) and conjunctival staining with fluorescein (p = 0.04) showed significant improvement in scores in the autologous-serum group compared to that of the unpreserved hypromellose group at 2 weeks. After 8 weeks of treatment, however, differences in staining scores, Schirmer test, and TBUT were not significant. The OSDI (p = 0.002) showed significantly greater improvement in the autologous-serum group than in the unpreserved hypromellose group.

Conclusions: Use of both 20% autologous-serum eye drops  andunpreserved hypromellose is safe and effective as singletreatment for aqueous-tear-deficient dry-eye disease. How-ever, dry-eye condition improved earlier among patientsin  the  autologous-serum group than those in  theunpreserved hypromellose group, and provided greaterfunctional improvement and symptomatic relief.