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. 2025 May;42(5):2219-2233.
doi: 10.1007/s12325-025-03139-1. Epub 2025 Mar 13.

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

Laure Chauchat  1 , Camille Guerin  2 , Marwan Sahyoun  2 , Michel Guillon  3 , Margarita Calonge  4   5
Affiliations

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

Laure Chauchat et al. Adv Ther. 2025 May.

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.

Keywords: Alpha-lipoic acid; Dry eye disease; Emulsion; Eye drop; High molecular weight sodium hyaluronate; Inflammation; Oxidative stress; SODase.

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Conflict of interest statement

Declarations. Conflict of Interest: Camille Guerin, Laure Chauchat and Marwan Sahyoun were working for Horus Pharma at the time of publication. Michel Guillon was contracted by Horus Pharma to serve as the Clinical Research Organisation for this clinical trial. Margarita Calonge had nothing to disclose. Ethical Approval: The study was approved by the Integrated Research Application System (IRAS; Centralized National Research Ethics Service) of the East of England—Cambridge Central Research Ethics Committee under the reference number 19/EE/0315. The study was conducted in accordance with the current ethical principles of the Declaration of Helsinki and in accordance with the current legislation on clinical research in UK. All patients were given and understood the Participant Information Sheet in English; and read, signed, and dated an informed consent form before starting the study. The study was registered in the ISRCTN database under number 17861788.

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