Evaluation of ocular surface disease symptoms and patient satisfaction in dry eye disease after 84 days of treatment with preservative‐free eye drops containing sodium hyaluronate and trehalose

Abstract

AbstractPurposeDry 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.MethodsMulti‐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).ResultsData 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.ConclusionsResults 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.