Patient‐reported outcomes measurements in dry eye patients after 84 days of daily treatment with a preservative‐free combination containing sodium hyaluronate and trehalose: The TEARS study

Abstract

AbstractPurpose: Dry eye disease (DED) is characterized by ocular discomfort and visual disturbance that can impact quality of life. This study evaluated, after 84 days of daily use, the improvement of ocular surface disease (OSD) and various Patient‐Reported Outcomes Measurements (PROM) in patients with DED receiving a preservative‐free combination containing sodium hyaluronate and trehalose (SH‐THL, Thealoz® Duo, Laboratoires Théa).Methods: This is a multicenter, non‐interventional survey in 312 adult subjects with DED. Clinical tests and Ocular Surface Disease Index (OSDI®) were performed at baseline and Day 84. Dry Eye Questionnaire (DEQ‐5) was done at baseline, 28 days and 84 days, as well as other PROM related to satisfaction, eye drop, comfort and impact on life's activities. SH‐THL was to be instilled when needed.Results: 82.4% were women, the mean age was 57.9 ± 15.2 years. At baseline (BL), the overall OSDI was 41.7 ± 20.6 (60.3% of patients had a severe score, i.e. between 33–100) and significantly improved after 84 days to 27.3 ± 19.8 (34.5% of patients with a severe score). Similarly, the DEQ‐5 score significantly improved at 28‐day and 84‐day visits (p < 0.001 compared to BL). Patient satisfaction with treatment significantly improved at all visits (p < 0.001 compared to BL). 72.3% preferred SH‐THL to their previous treatment after 84 days. There was a statistically significant difference in the overall scores of the impact on patient's life and the eye drop questionnaires, at all visits: 80.3% agreed on “My current drops make my eyes comfortable” at Day 84; 38.6% reported No Impact on working on a computer and 68.1% reported No Impact on sleeping at Day 84.Conclusions: The OSDI mean improvement of −14.4 points over time was higher than the minimal important difference reported in literature. Eye drops containing SH‐THL improved significantly after 84 days the Patient‐Reported Outcomes Measurements on satisfaction, eye drop, comfort and impact on life's activities in Dry Eye patients in a real‐world setting.