PurposeDry 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.
PurposeTo analyze the rheological behaviours of several artificial tears.MethodsIn vitro viscosity profile of the different artificial tears was obtained. A cone‐plate rotational rheometer was used with ascending and descending shear rate (from 1 s‐1 to 1000 s‐1, 330 measurements) at a constant temperature of 30°C and a fluid volume of 5 ml. The difference between viscosities in each section of shear rate was calculated.ResultsFour different rheological patterns were found in 78 artificial tears: shear‐thinning, shear‐thickening, thixotropic and Newtonian. Thixotropy was found between 0.17 and 104.576 mPas. Shear‐thinning, shear‐thickening and Newtonian behaviours showed a variation in viscosity in the last measurement section between −1.22 and 517 mPas.DiscussionThe viscosity of artificial tears always depends on the shear rate. It is possible to find two patterns simultaneously depending on the shear rate. These rheological patterns could serve to optimize the treatment with lubricants in different conditions of the ocular surface.ConclusionsThe variation of the shear rate conditions the viscous behavior of the fluids. We have defined four possible rheological models in the measured artificial tears. In vivo studies are necessary to evaluate the clinical utility of these findings.Bibliography Bhushan B. Introduction To Tribology. 2nd ed. New York: John Wiley & Sons, Inc; 2013. 711 p. Simmons PA, Aragona P, Wang H, Wang T. Physiochemical Properties of Hyaluronic Acid‐based Eye Drops. Montpellier, France; 2016. Lievens C, Berdy G, Douglass D, Montaquila S, Lin H, Simmons P, et al. Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double‐masked, randomized 30‐day study. Contact Lens Anterior Eye. 2019;42(4):443–9. Pult H, Tosatti SGP, Spencer ND, Asfour JM, Ebenhoch M, Murphy PJ. Spontaneous Blinking from a Tribological Viewpoint. Ocul Surf. 2015;13(3):236–49.
Purpose: 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.
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