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.