Multicentric Clinical Investigation On The Use Of Preservative-Free Ophthalmic Solution Based On Sodium Hyaluronate, Osmoprotectants, And Xanthan Gum In The Treatment Of Eye Discomfort, Particularly In Dry Eye.

The purpose of this investigation is to report the treatment outcomes of a new ophthalmic solution containing sodium hyaluronate, osmoprotectants,  and xanthan gum after three months of treatment in patients with dry eye disease (DED).

This was a multicenter, prospective, observational, open-label, clinical investigation. The patients from ophthalmological general clinics were included between 14/03/2023 and 06/10/2023. Patients were treated with one drop four times a day.

Multicenter study centers in Spain: 

- Hospital Clínico San Carlos. Madrid.

- Hospital la Arruzafa. Córdoba.

- Clínica Oftalvist. Alicante.

- Hospital Miguel Servet. Zaragoza.

Multicenter, prospective, observational study. Thirty-five patients were included. 

Signs and symptoms were evaluated at the inclusion visit(V1) and after 15(V2), 30(V3) and 90 days(V4) of treatment, including dry eye symptoms using SANDE Questionnaire, fluorescein staining through NEI score (primary endpoint at one month), hyperemia index with Keratograph (Oculus, Wetzlar, Germany), tear film break-up time (TFBUT), best corrected visual acuity (BCVA - ETDRS chart). Moreover, Dry Eye Quality of life Symptoms (DEQS), Investigator Global Assessment of Safety (IGAS), and intraocular pressure (IOP) were also evaluated. Paired t-test was used to compare findings before and after treatment. A p value <0.05 was considered statistically significant.

Thirty-two patients (mean age 59.4 (±13.8 years) completed the three-month period of treatment. Concerning performance at third month, corneal and conjunctival fluorescein staining decreased significantly (score 3.91±3.3)  compared to day 0 (score 11.52±3.2) with a difference of -7.61(±4) points (p=0.001) and TBUT increased significantly (1.98 seconds; p=0.001). Dry eye symptoms (SANDE) decreased significantly (total score: -26.41 (±24) points, p=0.001 so did frequency and severity (-25.87 (±26.7) points and -27,20 (±22.6) points; p=0.001, respectively). The DEQS Score improved significantly (-18.43 (±19.3) points; p=0.001) together with the impact on daily life and the bothersome ocular symptoms (p=0.001). No changes in BCVA or IOP.

The investigation showed that the preservative-free ophthalmic solution based on sodium hyaluronate, xanthan gum and osmoprotectants were able to improve significantly, already after one month of treatment, signs, symptoms, and quality of life of DED patients. The performances of the medical device were confirmed after a follow-up of three months. No safety issue was reported.