A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1 % hyaluronic acid in diabetic patients with dry eye disease.

Abstract Title: A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease. {1} Background The global prevalence of diabetes mellitus (DM) continues to rise and 70% of diabetic individuals have dry eye disease (DED) that leads to subsequent abnormalities of the corneal epithelium, corneal nerves, tear film, or corneal endothelium. In addition, persons with diabetes produce less tear secretions than healthy individuals. While several anti-inflammatory drug-based therapies for dry eye in diabetic individuals are currently be administered but their efficacy not been studied in detail. Therefore, the aim of this study was to compare the effectiveness of 3% diquafosol (DQS) vs 0.1% hyaluronic acid (HA) eye drops in diabetic related dry eye patients. Methods and analysis: This single-blind randomized, control trial will include 140 diabetic related DED and will be assigned to DQS (n = 101) and HA (n = 101) one drop, six times per day for 8 weeks. Tear film lipid layer, non-invasive breakup time, cornea conjunctival staining score, corneal sensitivity, tear MMP-9 levels, meibum gland, tear meniscus height, corneal nerves and immune/inflammatory cells change, conjunctival hyperemia, ocular surface disease index questionnaire score will be assessed and compared at baseline, week-4, and week-8. Discussion This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of DQS and HA for diabetic related dry eye treatment. Ethics and dissemination: This study will be approved by the Ethics Committee of He Eye Specialist Hospital [ethics approval number: IRB (2022) K002.01]. Prior to participating in the trial, all patients will provide written informed permission. The outcomes of this study will be presented at local and international conferences and submitted for publication in journals with peer review. Trial registration number : Clinicaltrials.gov NCT04980144 {2a, 2b}