Abstract
Purpose :
Dry eye has been defined as a multifactorial disease of the ocular surface, which is characterized by tear film instability, inflammation and ocular surface damage. Our purpose was to evaluate the performance and safety of a novel single-dose eye drop containing xanthan gum 0.2% and low concentration desonide sodium phosphate at 0.025% in patients with ocular discomfort due to dry eye.
Methods :
Multicenter, prospective, observational, open label, non-interventional clinical investigation evaluating the performance and safety of the study eye drop in 30 patients (9 males, 21 females, age 60.28±14.23 years) with mild to moderate dry eye of different aetiologies used 3 times/day for 1 month. The following parameters were assessed during the 3 scheduled visits at day 0, day 14 and day 30: conjunctival hyperemia score (assessed by OCULUS Keratograph), epithelial ocular surface damage assessed by corneal-conjunctival staining (scored according to the National Eye Institute [NEI] scale), tear film break-up time (TFBUT), dry eye symptomatology and quality of life respectively scored by SANDE and NEI-VFQ25 questionnaire, safety (intraocular pressure).
Results :
A statistically significant reduction has been observed from D0 to D30 for conjunctival hyperemia score (from 1.95 ± 0.37 to 1.44 ± 0.55, p<0.001) and for corneal-conjunctival fluorescein staining score (from 15.06 ± 6.43 to 10.76 ± 6.78, p=0.001) while a statistically significant increase was found for TFBUT (from 4.07 ± 1.65 to 5.58 ± 2.39 seconds, p=0.0005). SANDE questionnaire showed a reduction of the intensity and frequency of ocular discomfort symptoms (from 72.13 ± 15.17 to 46.83±22.22, p<0.001). Regarding quality of life, a significant improvement has been also reported. No safety issue has been observed, in particular intraocular pressure values remained stable throughout the study.
Conclusions :
This is the first clinical investigation conducted with this new eye drop containing 0.2% xanthan and 0.025% desonide sodium phosphate. The significant amelioration of all investigated signs and symptoms has been reported in patients with mild to moderate dry eye after 1 month treatment; a good safety profile has been also highlighted.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.