ArticleOphthalmology and therapy2025
Performance and Safety of a Sodium Hyaluronate, Xanthan Gum, and Osmoprotectants Ophthalmic Solution in the Treatment of Dry Eye Disease: An Observational Clinical Investigation.
Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05778942 (Multicentric Clinical Investigation on the Use of Preservative-Free Ophthalmic Solution Based on Sodium Hyaluronate and Xanthan Gum in the Treatment of Eye Discomfort, in Particular in Case of Ocular Dryness), which is not on this map. Cited by 3 papers.
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Multicentric Clinical Investigation on the Use of Preservative-Free Ophthalmic Solution Based on Sodium Hyaluronate and Xanthan Gum in the Treatment of Eye Discomfort, in Particular in Case of Ocular Dryness
Who cites it
3 citing papers in PubMed.
- Chrysanthemum indicum L.-derived extracellular vesicles enhance the therapeutic efficacy of cyclosporine a against dry eye disease.Journal of nanobiotechnology · 2026Article
- Antibiotic nanozyme hydrogel depot for single-injection MDR bacterial keratitis therapyMaterials today. Bio · 2026Article
- Hyperosmolarity-Induced Oxidative Stress Leads to Senescence in Human Corneal Epithelial Cells (HCEPC) via DNA Damage, Metabolic Disturbance and Mitophagy Decline.Antioxidants (Basel, Switzerland) · 2025Article
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Authors and funding
16 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionDry eye disease (DED) is characterized by an imbalance in the tear film, resulting in symptoms such as dryness, redness, and discomfort. The management of DED involves tear supplements, medications, or surgery in severe cases. To evaluate the clinical performance and safety of a hypotonic ophthalmic solution containing sodium hyaluronate 0.2%, xanthan gum 0.2%, and osmoprotectants (glycine and betaine) for treating DED.
methodsThis multicenter, prospective, observational clinical investigation included 35 subjects treated with one drop of the ophthalmic solution four times daily. Evaluations were conducted at baseline, on day 14, and at 1 and 3 months. The investigation assessed corneal and conjunctival fluorescein staining (NEI score), hyperemia index (Keratograph®), fluorescein tear film break-up time (TFBUT), best-corrected visual acuity, dry eye symptoms (SANDE), and quality of life (DEQS). Safety was monitored through adverse events, intraocular pressure measurements, and the Investigator Global Assessment of Safety.
resultsSubjects were predominantly female (93.9%), with an average age of 59.9 ± 13.8 years. The ophthalmic solution significantly reduced keratitis lesions with global NEI score decreasing from baseline at 1 month (- 6.67 ± 4.6, p = 0.001) and 3 months (- 7.61 ± 4.0 points; p = 0.001). Conjunctival hyperemia improved significantly after 1 month (- 0.34 ± 0.7 points; p = 0.027), while fluorescein tear film stability increased significantly at 1 (1.85 ± 3.1 s; p = 0.002) and 3 months (1.98 ± 3.4 s; p = 0.001). Symptoms also improved significantly (p = 0.001) at 1 and 3 months (- 29.37 ± 22.2 points and - 26.41 ± 24.0 points, respectively), as did quality of life (- 20.81 ± 15.6 points at 1 month and - 18.43 ± 19.3 points at 3 months; p = 0.001 for both). The safety profile was very good, with no adverse events (only mild ocular discomfort reported in 14.3% of subjects).
conclusionsThe ophthalmic solution effectively improved DED symptoms and signs, enhancing patients' quality of life while maintaining a good safety profile. TRIAL REGISTRATION NUMBER: NCT05778942.
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