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.

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.