Clinical performance of preservative‐free, hypotonic solution of 0.15% sodium hyaluronate for mild to moderate dry eye

Purpose The viscoelastic and hydration properties of Hyaluronic Acid (HA) make it the ingredient of choice in modern topical formulations for relief of dry eye symptoms, but there are few that present it as a hypotonic preparation without preservatives, both properties known to be beneficial for dry eye management. This study was designed to investigate the patient satisfaction and clinical performance of Hyabak (R) (Laboratoires Thea, France) in a group of volunteers with mild to moderate dry eye symptoms. Methods Thirty volunteers (8M, 22F; mean age 66.6 (SD 9.9) years) with mild to moderate dry eye symptoms, as assessed by the Ocular Surface Disease Index (OSDI) questionnaire), were recruited from an older population around Plymouth, UK. Participants were assessed at baseline and after 10 days of treatment with Hyabak (4 drops daily to each eye). The following was recorded at each visit: bulbar and limbal redness, corneal and conjunctival staining, tear film stability, ocular comfort using visual analogue scales (VAS) and OSDI scores. Results Ocular comfort and OSDI scores showed significant improvements by day 10 (by 35% and 34% respectively; p<0.001). Average cornea and conjunctival staining decreased by 50% and 56% (both p<0.001), respectively. Improvements in bulbar and limbal redness were significant (p<0.001), and the improvement in tear film stability after 10 days was statistically significant (p<0.001) but clinically small (average increase +1.1 seconds) Conclusion Statistically and clinically significant improvements in the key clinical indicators of success, including patient comfort, can be seen after only ten days using this preservative‐free, hypotonic formulation in mild to moderate dry eye.Commercial interest