Background: To assess the clinical efficacy, tolerability and safety of a new-generation
ophthalmic solution containing cross-linked
hyaluronic acid 0.15%
trehalose 3%,
liposomes 1% and
sterylamine 0.25% (Trimix® Off Health Italia, Firenze, Italy) (CXHAL) versus
trehalose 3% (Thealoz®, Thea
Pharmaceuticals, Clermont-Ferrand, France) (TRS) in subjects with moderate to severe
dry eye disease (DED). Patients and methods: In this prospective, observational cohort study, 41 subjects with moderate to severe
dry eye were enrolled and divided into two age- and sex-matched groups. Group 1 was treated with CXHA
eye drops, and group 2 was treated with TRS
eye drops four times daily for 2 months. All subjects were evaluated at baseline (V0) and at day 60 ± 3 (V1). The examination comprised Best Corrected Visual Acuity (BCVA) and Symptom Assessment in
Dry Eye (SANDE). Tear osmolarity was evaluated using the TearLab Osmolarity System®; Keratograph 5M (Oculus, Wetzlar, Germany) was performed to assess tear meniscus height (TMH),
fluorescein tear break-up time (TBUT) and corneal and conjunctival
fluorescein staining and meibography; furthermore,
slit lamp evaluation was performed for eyelid
erythema and
edema, conjunctival chemosis and
hyperemia and Meibomian gland secretion quality. Results: All patients completed the treatment. BCVA remained stable in both groups, and no adverse events were reported. After 2 months, both groups showed statistically significant improvements for SANDE (p = 0.001 and p = 0.012, respectively), TBUT values (p < 0.001 and p < 0.001, respectively) and staining (p = 0.004 and p = 0.001, respectively) as compared to baseline values. Group 1 showed a statistically significant improvement in SANDE frequency and tear osmolarity (p = 0.02 and p = 0.001, respectively), whereas chemosis was significantly reduced in group 2. The amount of TBUT improvement was statistically higher in group 1 compared to that in group 2 (p = 0.041). Conclusion: A new-generation multiple-action
ophthalmic solution was safe and clinically effective in the treatment of moderate and severe
dry eye, with significant improvements in the main ocular surface parameters.