Name

Vision et confort oculaire chez les patients atteints de sécheresse oculaire modérée à sévère traités par une émulsion lipidique ophtalmique sans conservateur contenant du hyaluronate de sodium

While common dry eye complaints are often vision related, quality of life, as well as patient comfort, should remain at the heart of dry eye management. The study purpose was to evaluate vision and ocular comfort of patients with moderate to severe dry eye disease treated with a preservative free ophthalmic lipidic emulsion eyedrop containing sodium hyaluronate.

A prospective, non-randomized, investigator masked study was conducted on 40 symptomatic dry eye patients from different aetiologies. After at least 7 days of washout, patients were treated with a preservative free ophthalmic lipidic emulsion eyedrop containing sodium hyaluronate (4-6 times/day) for 35 days. The following endpoints were assessed at the 2 scheduled visits (D0&D35): ocular comfort (0-100 VAS score); functional vision quality at low and high contrasts (Landolt rings); dry eye symptomatology (quality of life OSDI score); tear film stability (non-invasive break-up time); and safety. A secure phone application was used every 4 days (3 time-points/day) to control ocular comfort and vision satisfaction (0-100 VAS score). Statistical analysis was performed (paired t-test and Wilcoxon; p<0.05).

Ocular comfort was highly statistically and clinically improved at D35 with a mean VAS score increase of 17.9 points (40.3%; p<0.001) compared to D0. Results were also confirmed via the phone application for the 3 time-points throughout the follow-up (19.8%-51.0% overall improvement; p=0.035-0.004). All other endpoints were statistically significant at D35 compared to baseline: gain in visual acuity for high (p=0.021) and more challenging low (p=0.001) contrasts; improvement of the OSDI score (p<0.01); and increase of the non-invasive break-up time (p=0.03). Tested vision satisfaction was statistically and clinically enhanced for all 3 timepoints of the day (p=0.031 to 0.003) compared to D0. No major safety issues were reported.

During the last decade and more particularly following the COVID-19 sanitary crisis, our environment has been constantly evolving towards a digital era that, in association with face-mask wearing, contributes to increased moderate to severe dry eye disease. By mirroring the demands of modern device-based vision requirements, Landolt rings quantify and challenge real life visual acuity. Also, the regular phone application evaluation allows for qualitative comfort and vision data collection.

The use of a preservative free ophthalmic lipidic emulsion eyedrop containing sodium hyaluronate enhanced comfort and vision of moderate to severe dry eye patients of different aetiologies. The beneficial effects of such emulsion could be due to its lacrymimetic activity through the lipid integration with the tear film lipid layer along with the mucomimetic activity of hyaluronic acid which grant better tear film stability. As our lifestyle is constantly changing with increased screen use and mask-associated dry eye, incorporating vision-related quality of life evaluation provides further positive insight on the beneficial effect of our tested eyedrop. [This research was supported by grants from Horus Pharma]