A randomized controlled trial involving college student: Comparing 0.15% hyaluronic acid with 0.05% cyclosporine A and 3% diquafosol sodium in the Treatment of Dry Eye

Abstract

Background: To compare the efficacy of 0.15% hyaluronic acid (HA), 0.05% cyclosporine A (CsA) and 3% diquafosol sodium (DQS) ophthalmic solution for the treatment of moderate-to-severe dry eye disease (DED) in college students and the effect on inflammatory factors in tears. Methods: This was a prospective, randomized, multicenter trial. A total of 282 college students diagnosed with moderate-to-severe DED between October 2, 2022 and March 1, 2023 were included. A total of 282 patients were randomized to treatment in the group of 0.15% HA or 0.05% CsA or 3% DQS in a 1:1:1 assignment. There was a main end point which is the variations in the corneal staining score to determine non-inferiority of 0.15% HA. Secondary target end points were ocular surface disease index score, Schirmer test, tear meniscus height and tear film breakup time. In addition, the inflammatory factor levels of Interleukin-1β, Interleukin-6, transforming growth factor-β1 in tears were measured. Effectiveness was assessed at baseline, 4- and 12-weeks. Results: In our analysis, the average change from baseline in corneal staining score confirmed non-inferiority of 0.15% HA to 0.05% CsA and 3% DQS and manifested obvious improvement of all groups as well (P < .05). Values for ocular surface disease index score, Schirmer test, tear meniscus height and tear film breakup time showed obvious improvements in all groups (P < .05), however, the difference intergroup was not statistically significant. Value for inflammatory factor was significant improvement across all groups, although inflammatory factor scores in the 0.05% CsA group showed a clear trend of better improvement at 12 weeks compared with 0.15% HA groups (P < .01). No serious adverse reactions were observed. Conclusions: College students taking 0.15% HA had clinically and statistically significant improvement in corneal staining score and other indicators, but it was inferior to 0.05% CsA in anti-inflammatory therapy for moderate to severe DED. However, 0.15% HA is still an effective, safe and well-tolerated treatment option that may offer additional benefits in terms of convenience and compliance.

Efficacy of topical 0.05% cyclosporine A and 0.1% sodium hyaluronate in post-refractive surgery chronic dry eye patients with ocular pain

“…Tear film instability increases the risk of corneal epithelial injury, which leads to the release of inflammatory mediators. Immune cells on the ocular surface release a large number of proinflammatory cytokines, which recruit more immune cells to accumulate on the ocular surface, leading to a vicious circle of inflammation [ 35 ]. This study showed a significant reduction in tear inflammatory cytokine levels at 3 months.…”