Efficacy and Safety of 0.3% Preservative-Free Hyaluronic Acid-Based Eye Drops for the Management of Moderate to Severe Dry Eye Disease: A Prospective, Multicenter, Clinical Investigation.

PURPOSE: Dry eye disease (DED) is a prevalent and chronic condition with multifactorial etiology. This study evaluated the efficacy and safety of a isotonic, preservative-free 0.3% hyaluronic acid (HA)-based ophthalmic solution (BLUgel A free), in patients with moderate-to-severe DED.

PATIENTS AND

METHODS

This multicenter, prospective, post-market investigation enrolled 51 patients receiving HA eye drops. Most participants had comorbidities and were on polytherapy. Outcomes included changes in NEI grading scale, tear-film break-up time (TFBUT), Schirmer's test I, IDEEL questionnaire scores, non-invasive Break-Up Time (niBUT), tear meniscus height, conjunctival hyperaemia and meibography, assessed at 30 and 60 days.

RESULTS

A significant improvement in ocular surface integrity was observed throughout the study period. The NEI score decreased markedly from 8.38 ± 2.17 at baseline to 4.04 ± 2.93 after 30 days and further to 3.60 ± 3.30 at 60 days. Tear-film stability also improved, with TFBUT increasing significantly from 3.65 seconds at baseline to 6.51 seconds on day 30, and 7.26 seconds on day 60. Tear production, assessed by Schirmer's test, increased from 5.70 ± 2.82 mm to 8.74 ± 3.94 mm and then to 9.62 ± 4.57 mm over the same period. Patient-reported outcomes reflected these clinical improvements: IDEEL symptoms-bother scores dropped from 58.82 ± 10.57 to 40.99 ± 11.09, surpassing the clinically meaningful threshold of 12 points. Safety was confirmed, with only one minor adverse event (blurred vision) reported.

CONCLUSION

0.30% HA-based eye drops proved to be an effective and well-tolerated treatment for moderate-to-severe DED, offering clinical benefits even in patients receiving concomitant systemic therapies.