Comparison of the effect of a hyaluronate-trehalose solution to hyaluronate alone on Ocular Surface Disease Index in patients with moderate to severe dry eye disease.

OBJECTIVE: To describe a post hoc analysis comparing the effect of a hyaluronic acid (HA)-trehalose solution to an established eyedrop solution containing HA alone using Ocular Surface Disease Index (OSDI) score <19 as a threshold for moderate to severe dry eye disease (DED).

METHODS: A phase III, randomized, controlled, single-blind, multicenter study was conducted in France and Tunisia to evaluate the efficacy and safety of HA-trehalose (N = 52) and HA (N = 53) administered for 84 days. Eligible patients had moderate to severe DED with OSDI ≥18. Here the results of a post hoc analysis of the percentage of patients with OSDI <19 on Day 35 and Day 84 are reported.

RESULTS: Significantly more patients had OSDI <19 at Day 84 in the HA-trehalose group than in the HA group (78.8% versus 58.5%; p = .025). At Day 35, more patients had OSDI <19 in the HA-trehalose group than in the HA group, but this difference was not statistically significant. Furthermore, approximately twice as many patients in the HA group (41.5%) still had OSDI 19-100 at Day 84 compared to the HA-trehalose group (21.2%).

CONCLUSIONS: This data supports the addition of trehalose to HA-containing eyedrop solutions to provide better symptomatic relief from moderate to severe DED, based on an OSDI score of <19 after 84 days of treatment.