A Preservative-Free Combination of Sodium Hyaluronate and Trehalose Improves Dry Eye Signs and Symptoms and Increases Patient Satisfaction in Real-Life Settings: The TEARS Study.

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-21 DOI:10.1007/s40123-024-01044-4

Antonio J Mateo-Orobia, Sarah Farrant, Eduardo Del-Prado-Sanz, Alejandro Blasco-Martínez, Miriam Idoipe-Corta, Noelia Lafuente-Ojeda, Luis E Pablo-Júlvez

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引用次数: 0

Abstract

Introduction: Dry eye disease (DED) is a frequently observed condition characterized by ocular discomfort and visual disturbance. It is highly prevalent and impairs patients' quality of life (QoL). This study assessed the benefit of a preservative-free bioprotectant eye drop formulation containing sodium hyaluronate and trehalose (SH-trehalose) with regards to DED, as well as patient satisfaction, through a large-scale real-life survey.

Methods: In a multi-center, international, prospective observational study, subjects with DED received SH-trehalose for 84 days. Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire-5 items (DEQ-5), and patient satisfaction were assessed at baseline, day 28, and day 84, and clinical evaluations included ocular surface staining, Schirmer test, tear film break-up time (TBUT), and conjunctival hyperemia at baseline and day 84.

Results: A total of 312 patients were evaluated, of whom 82.4% were women. The mean age was 57.9 ± 15.2 years. The mean OSDI score at baseline was 41.7 ± 20.6. After 84 days, the mean OSDI score was 27.3 ± 19.8 (p < 0.001). The percentage of patients with a severe OSDI score decreased from 60.3 to 34.5%. The DEQ-5 score significantly (p < 0.001) improved after 28 and 84 days, as did patient satisfaction. Ocular surface staining, Schirmer test, TBUT, and conjunctival hyperemia scores improved significantly (all p < 0.001) for both eyes with SH-trehalose between baseline and day 84. Tolerance of SH-trehalose was good.

Conclusions: SH-trehalose significantly improved the clinical signs and symptoms of DED after 84 days. Moreover, it significantly increased patient satisfaction and was well tolerated.

Trial registration: NCT04803240.

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不含防腐剂的透明质酸钠和曲哈洛糖复方制剂可改善干眼症症状，提高患者在实际生活中的满意度：TEARS研究。

简介干眼症（DED）是一种常见病，以眼部不适和视力障碍为特征。干眼症发病率很高，会损害患者的生活质量（QoL）。本研究通过一项大规模的实际调查，评估了不含防腐剂的生物保护剂滴眼液配方（含透明质酸钠和曲哈洛糖，SH-曲哈洛糖）对干眼症的益处以及患者的满意度：在一项多中心、国际性、前瞻性观察研究中，患有 DED 的受试者接受了为期 84 天的 SH-曲哈洛糖治疗。在基线、第 28 天和第 84 天评估眼表疾病指数 (OSDI)、干眼症问卷-5 项目 (DEQ-5) 和患者满意度，临床评估包括基线和第 84 天的眼表染色、Schirmer 试验、泪膜破裂时间 (TBUT) 和结膜充血：共对 312 名患者进行了评估，其中 82.4% 为女性。平均年龄为 57.9±15.2 岁。基线时的平均 OSDI 得分为 41.7 ± 20.6。84 天后，OSDI 平均得分为（27.3 ± 19.8）（P 结论：SH-曲哈洛糖显著改善了患者的心肌梗死症状：84 天后，SH-曲哈洛糖明显改善了 DED 的临床症状和体征。此外，它还能明显提高患者的满意度，且耐受性良好：试验注册：NCT04803240。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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