Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patients with Moderate to Severe Dry Eye: A Randomized Double-blind Controlled Trial.

Abstract

Background: Dry eye disease (DED) is a prevalent ocular condition, particularly in Asian populations, that adversely affects quality of life and visual function. While sodium hyaluronate (SH) artificial tears are commonly used, the optimal concentration remains unclear. This study compared the efficacy and safety of 0.28% versus 0.18% SH eye drops in patients with moderate to severe DED.
Methods: In this prospective, multicenter, randomized, double-blind controlled trial, patients with moderate to severe DED (OSDI ≥ 23, Oxford grading scale ≥ 2, FTBUT < 7 seconds) were randomized to receive either 0.28% or 0.18% SH eye drops in both eyes, six times daily for 30 days. The primary outcome was change in Oxford grading scale. Secondary outcomes included tear osmolarity, best corrected visual acuity (BCVA), fluorescein tear break-up time (FTBUT), ocular surface disease index (OSDI), quality of life (DEQS-Th), and adverse events, assessed at baseline and after 30 days.
Results: Forty-six patients (92 eyes) were enrolled. The 0.28% SH group showed a significantly greater reduction in Oxford grading scale scores at 30 days compared to the 0.18% group (p = 0.024), with improvement in 91.3% versus 73.9% of patients, respectively (p = 0.021). The 0.28% SH group also achieved a clinically significant reduction in tear osmolarity post-instillation. BCVA improved significantly only in the 0.28% SH group, whereas FTBUT increased in both groups. In addition, both groups improved in OSDI and DEQS-Th scores, with no significant difference between groups. Adverse events were mild and similar between groups.
Conclusions: The 0.28% SH eye drops are safe and effective for treating moderate to severe DED, significantly reducing corneal staining and dry eye symptoms, and improving visual acuity and quality of life.
Conflict of I nterest: The authors declare no competing interest.