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Introduction <p>Dry 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.</p> Methods <p>This 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&#xa0;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.</p> Results <p>Subjects were predominantly female (93.9%), with an average age of 59.9 ± 13.8&#xa0;years. The ophthalmic solution significantly reduced keratitis lesions with global NEI score decreasing from baseline at 1&#xa0;month (−&#xa0;6.67 ± 4.6, <i>p</i> = 0.001) and 3 months (−&#xa0;7.61 ± 4.0 points; <i>p</i> = 0.001). Conjunctival hyperemia improved significantly after 1&#xa0;month (−&#xa0;0.34 ± 0.7 points; <i>p</i> = 0.027), while fluorescein tear film stability increased significantly at 1 (1.85 ± 3.1&#xa0;s; <i>p</i> = 0.002) and 3 months (1.98 ± 3.4&#xa0;s; <i>p</i> = 0.001). Symptoms also improved significantly (<i>p</i> = 0.001) at 1 and 3 months (−&#xa0;29.37 ± 22.2 points and −&#xa0;26.41 ± 24.0 points, respectively), as did quality of life (−&#xa0;20.81 ± 15.6 points at 1&#xa0;month and −&#xa0;18.43 ± 19.3 points at 3&#xa0;months; <i>p</i> = 0.001 for both). The safety profile was very good, with no adverse events (only mild ocular discomfort reported in 14.3% of subjects).</p> Conclusions <p>The ophthalmic solution effectively improved DED symptoms and signs, enhancing patients' quality of life while maintaining a good safety profile.</p> Trial Registration Number <p>NCT05778942.</p>

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Performance and Safety of a Sodium Hyaluronate, Xanthan Gum, and Osmoprotectants Ophthalmic Solution in the Treatment of Dry Eye Disease: An Observational Clinical Investigation

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  • 发表日期：

    2025年2月21日

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  • Mercedes Molero Senosiaín,
  • Barbara Burgos-Blasco,
  • Pilar Perez-García,
  • Álvaro Sánchez-Ventosa,
  • Marta Villalba-González,
  • María Dolores López Pérez,
  • José Carlos Díaz,
  • Vanesa Díaz-Mesa,
  • Alberto Villarrubia Cuadrado,
  • Enrique Artiaga Elordi,
  • Jose Manuel Larrosa Poves,
  • Alejandro Blasco,
  • Antonio Mateo,
  • Claudine Civiale,
  • Laura Bonino,
  • Antonio Cano-Ortiz

摘要

Introduction

Dry 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.

Methods

This 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.

Results

Subjects 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).

Conclusions

The ophthalmic solution effectively improved DED symptoms and signs, enhancing patients' quality of life while maintaining a good safety profile.

Trial Registration Number

NCT05778942.