The Impact of 3% Diquafosol Ophthalmic Solution on Tear Film and Corneal Nerve Density in Patients with Diabetes and Dry Eye Disease: A Randomized Controlled Study

Abstract

Introduction: To investigate the effects of 3% diquafosol ophthalmic solution (DQS) on tear film and corneal nerve density in patients with diabetes and dry eye disease (DED). Methods: This randomized study included 99 diabetic participants with DED who received either DQS therapy (n = 100 eyes) or 0.1% hyaluronic acid (HA) therapy (n = 98 eyes) six times daily for 8 weeks. All participants were examined at baseline, week 4 (4W), and week 8 (8W) for non-invasive tear breakup time (NITBUT), redness score (RS), meibomian gland quality (MGQ), tear meniscus height (TMH), corneoconjunctival staining score (CFS), meibomian gland expression (MGEx), corneal sensitivity (CS), corneal nerve fiber density (CNFD), corneal nerve branch density (CNBD), corneal nerve fiber length (CNFL), tear film lipid layer (TFLL), and ocular surface disease index (OSDI). Results: At 8W, significant improvements in TMH, MGQ, CFS, and OSDI were found in two groups, while the DQS therapy also had significant improvements in NITBUT, MGEx, CS, CNFD, CNBD, and CNFL. A comparison between the DQS group and HA group found in the mean NITBUT (9.00 ± 6.56 vs. 6.95 ± 4.49 s, P = 0.011), TMH (0.25 ± 0.08 vs. 0.21 ± 0.08 mm, P = 0.004), RS Score (1.19 ± 0.36 vs. 1.53 ± 0.44, P < 0.001), TFLL (2.40 ± 0.49 vs. 2.84 ± 0.42, P < 0.001), MGEx (1.11 ± 0.82 vs. 1.39 ± 0.59, P = 0.007), MGQ (1.63 ± 0.49 vs. 1.97 ± 0.62, P < 0.001), CFS (1.06 ± 0.88 vs. 1.67 ± 1.35, P = 0.014), CS (5.93 ± 0.22 vs. 5.77 ± 0.55, P = 0.010), OSDI (14.56 ± 11.28 vs. 23.46 ± 12.32, P < 0.001), CNBD (39.58 ± 20.17 vs. 32.75 ± 20.95 no./mm2, P = 0.020), had significant difference. Conclusions: Both DQS and HA can improve the tear film of patients with diabetes and DED. DQS is more effective in treating DED compared to HA. Additionally, DQS may be beneficial for diabetic dry eye patients with corneal nerve damage. Trial Registration: ClinicalTrials.gov identifier, NCT05682547.