Efficacy and safety of a multi-action tear substitute based on 0.15% cross-linked hyaluronic acid, 3% trehalose and liposomes with stearylamine: A randomized, single-mask, controlled study

Purpose: To evaluate the efficacy and safety of TriMix, a new multiple-action tear substitute in patients with dry eye disease (DED). Methods: This was a randomized, multicenter, single-masked, hyaluronic acid (HA)-controlled clinical trial conducted between July, 2023 and May, 2024. A total of 115 patients were randomly allocated to receive either TriMix tear substitute or 0.15% HA tear substitute 3 times daily. Clinical outcomes include ocular surface disease index (OSDI) questionnaire, non-invasive tear film break-up time (NIBUT) and Schirmer I test (ST) without anesthesia at 3 and 6 months of follow-up. Results: Of the 115 patients randomized, 80 completed the study (TriMix, n = 56; HA, n = 24). At months 3 and 6, improvements from baseline were statistically greater with TriMix tear substitute compared to HA 0.15% tear substitute for OSDI: -3.7 points (95% CI, -6.9 to -0.6; p = 0.011) and − 7.5 points (95% CI, -10.3 to -4.6; p < 0.001), respectively. Similar results were reported for NIBUT: 0.9 s (95% CI, 0.3 to 1.6; P = 0.040) and 1.6 s (95% CI, 0.7 to 2.6; P < 0.001), respectively. Regarding safety, no serious ocular adverse events occurred. Three patients complained of burning after instillation of TriMix tear substitute. Conclusion: This RCTs demonstrate that TriMix tear substitute provides statistically significant and clinically evidence of the reduction of DED symptoms with a satisfactory safety profile through 6 months of follow-up. Findings suggest the use of this tear substitute, but results should be confirmed independently over longer time periods.