Efficacy and Safety of Gene III L-ergothioneine Eye Care Solution in Dry Eye Syndrome: A Randomized, Self-Controlled Clinical Trial

Abstract Purpose To evaluate the efficacy and safety of Gene III L-ergothioneine (EGT) Eye Care Solution for alleviating ocular discomfort in patients with dry eye syndrome (DES). Methods In this single-center, randomized, open-label, self-controlled trial, 40 DES patients were randomly assigned in a 1:1 ratio to one of two treatment groups: Group 1 received the Gene III EGT Eye Care Wash Solution via an eye wash cup (5 mL/vial), and Group 2 received the same formulation as Gene III EGT Eye Care Drops Solution (0.5 mL/vial). Outcomes were assessed at baseline and after 14 days using validated scales, including the Chinese Dry Eye Questionnaire, the Ocular Surface Disease Index (OSDI), and the Comprehensive Assessment of Visual Fatigue (CAVF), along with fluorescein tear film break-up time (TBUT). Results Combined analysis (N = 40) demonstrated significant improvements in dry eye symptoms with mean scores decreasing from 12.50 to 10.65 (P = 0.0353). Ocular Surface Disease Index (OSDI) scores improved from 12.25 to 9.2 (P = 0.0309), and visual fatigue, assessed by the CAVF scale, decreased from 11.18 to 6.60 (P = 0.0008). Significant increases in TBUT were observed in both groups, with left eye first TBUT rising in Group 1 (P = 0.0199) and Group 2 (P < 0.0001). No treatment-related adverse events were reported. Conclusion Gene III EGT Eye Care Solution effectively alleviated DES symptoms and demonstrated a favorable safety profile. Larger placebo-controlled trials are warranted to confirm these findings.