Management of Oxidative Stress and Inflammation in Patients with Symptomatic Dry Eye Disease Treated with a Preservative-Free Ophthalmic Emulsion Combining Alpha-Lipoic Acid and High Molecular Weight Sodium Hyaluronate

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-03-13 DOI:10.1007/s12325-025-03139-1

Laure Chauchat, Camille Guerin, Marwan Sahyoun, Michel Guillon, Margarita Calonge

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Abstract

Introduction

This study aimed to explore the beneficial effect of a preservative-free (PF) emulsion eyedrop combining high molecular weight sodium hyaluronate (HMW-HA) and alpha-lipoic acid on oxidative stress and ocular surface inflammation in patients with dry eye disease (DED).

Methods

In this prospective exploratory study, patients with moderate to severe DED symptoms were treated with the study eyedrop, 4–6 times/day for 1 month. Two visits were scheduled: baseline (D0) and after 35 days (D35). The following parameters were assessed: quality of life (OSDI score); superoxide dismutase (SODase) concentration in tears; goblet cell (GC) density (impression cytology); conjunctival hyperemia (Efron scale); corneal, conjunctival, and eyelid staining (Oxford scale); and meibomian gland (MG) blockage. Data were compared between D0 and D35 in subgroups of patients with a significant abnormality of the study outcome at baseline.

Results

Forty patients were involved, with a highly significant improvement of OSDI score at D35. The mean concentration of SODase significantly increased by 3.2 and 2.4 times for SODase1 and SODase2 respectively, in patients with deficient SODase at baseline. In patients with abnormal GC density at baseline, GC count increased by five times at D35. Conjunctival hyperemia and corneal staining scores significantly improved in the subpopulation of patients with a baseline grade ≥ 2. Eyelid margin staining was significantly reduced at D35 in patients with significant abnormalities at baseline. A significant reduction of MG obstruction was shown in the lower eyelid in patients with significant blockage at baseline.

Conclusion

The use of a PF ophthalmic emulsion combining alpha-lipoic acid and HMW-HA shows a beneficial effect on the ocular surface through the improved quality of life score. Noteworthy, patients presenting high oxidative and inflammatory conditions experienced significant improvement in oxidative stress and inflammation markers; this synergic effect is likely due to the well-known properties of alpha-lipoic acid and HMW-HA, enhancing DED management.

Trial Registration

ISRCTN.com identifier, 17861788.

查看原文本刊更多论文

含α -硫辛酸和高分子量透明质酸钠的无防腐剂眼液治疗干眼症患者的氧化应激和炎症的管理

前言：本研究旨在探讨由高分子量透明质酸钠（HMW-HA）和α -硫辛酸组成的无防腐剂（PF）乳剂滴眼液对干眼病（DED）患者氧化应激和眼表炎症的有益影响。方法：在本前瞻性探索性研究中，中重度DED患者使用研究滴眼液治疗，4-6次/天，持续1个月。计划两次访问：基线（D0）和35天后（D35）。评估以下参数：生活质量（OSDI评分）；泪液中超氧化物歧化酶（SODase）浓度；杯状细胞（GC）密度（印象细胞学）；结膜充血（Efron量表）；角膜、结膜和眼睑染色（牛津评分）；和睑板腺（MG）阻塞。比较基线研究结果有显著异常的患者亚组D0和D35的数据。结果：40例患者在D35时OSDI评分均有显著改善。在基线时SODase缺乏的患者中，SODase1和SODase2的平均浓度分别显著增加3.2倍和2.4倍。在基线时GC密度异常的患者中，D35时GC计数增加了5倍。在基线分级≥2的患者亚群中，结膜充血和角膜染色评分显著改善。在基线有明显异常的患者，眼睑边缘染色在D35处显著降低。在基线有明显阻塞的患者下眼睑MG阻塞显著减少。结论：联合α -硫辛酸和hw - ha的PF眼乳通过提高生活质量评分对眼表有有益作用。值得注意的是，出现高氧化和炎症状况的患者在氧化应激和炎症标志物方面有显著改善；这种协同效应可能是由于α -硫辛酸和HMW-HA众所周知的特性，增强了DED的管理。试验注册：ISRCTN.com标识符，17861788。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in 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. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.