Purpose

Dry eye disease (DED) has a multifactorial etiology, including insufficient tear production and/or excessive tear evaporation linked to multiple conditions. A preservative-free eye drop formulation containing sodium hyaluronate and trehalose (SH-THL, Thealoz® Duo) capitalizes on the bioprotectant properties of trehalose. This study evaluated the improvement of ocular surface disease (OSD), dry eye signs and symptoms, treatment satisfaction in patients with DED receiving SH-THL.

Methods

Multi-center, international, non-interventional prospective survey lasting 84 days with up to 2 post-baseline visits in up to 310 adult subjects with clinically confirmed DED requiring artificial tears. Clinical signs with Schirmer Test, tear Break Up Time, hyperemia, dry eye symptoms with OSDI® scale and the five-item dry eye questionnaire (DEQ-5) as well as patient satisfaction were assessed at baseline, visit 1 (28 days) and 2 (84 days). SH-THL was to be instilled when needed. The number of eye drops instilled per day was determined using the Kali Care Drop Meter (n=42).

Results

Data from 238 patients were analyzed. 83.2% were women, the mean age was 57.9 ± 15.1 years. At baseline, the overall OSDI was 42.2 ± 19.9 and 61.3% of patients had severe OSDI. The DEQ-5 score was 12.4±4.1 and the patient treatment satisfaction score was 6.4 ± 2.1. The OSDI significantly improved (p < 0.001) after 84 days. The DEQ-5 score significantly improved at visit 1, persisting until visit 2 (both p < 0.001) with a statistically significant (p = 0.002) difference between visit 1 and 2. Patient satisfaction with treatment significantly improved (p < 0.001) at visit 1 and 2 compared to baseline. All clinical signs significantly improved after 84 days of SH-THL.

Conclusions

Results confirm that continued use of eye drops containing SH-THL reduced DED signs and symptoms, OSDI scores, and result in a very high patient satisfaction.