Modified Sodium hyaluronate conjugated to riboflavin (Har® 0.1 %) as lubricant eyedrops in the treatment of dry eye: A prospective randomised study

Background: This study evaluates the therapeutic efficacy of HAr (R) (R) (a novel ophthalmic solution containing modified hyaluronic acid covalently linked to riboflavin) compared to hyaluronic acid eye drops in patients with dry eye disease (DED). Methods: Sixteen consecutive patients with bilateral medium to severe DED were divided into two groups. Group 1 received HAr (R) (R) 0.1 % (Ribohyal (R)), (R)), while Group 2 received HA 0.1 % eye drops. Parameters such as Ocular Surface Disease Index (OSDI) score, osmolarity, break-up time (BUT), non-invasive BUT (NIBUT), tear meniscus measurement, Schirmer test, and Oxford Staining were evaluated. This study has been successfully registered on ClinicalTrials.gov public (Identifier NCT06122428) Results: The Ribohyal group showed faster improvement in OSDI scores, with a statistically significant difference at 2 h (mean classification difference:-51.75; p = 0.0003). Photophobia significantly reduced at 2 h, 4 weeks, and 8 weeks in the Ribohyal group compared to baseline (p < 0.0001). Osmolarity improved significantly after 8 weeks in both groups (p < 0.0001). Conclusions: HAr (R) (R) 0.1 % (Ribohyal (R)) (R)) effectively reduced DED symptoms and improved photophobia within 2 h of instillation, lasting up to 8 weeks.