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Open Access 01-12-2023 | Xerophthalmia | Study protocol

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

Authors: Jiayan Chen, Yimeng Chen, Guanghao Qin, Liangzhe Li, Mingze Li, Yuan Cheng, Shuting Zhuang, Zhihui Li, Qing Zhang, Yi Wu, Lanting Yang, Salissou Moutari, Jonathan E. Moore, Ling Xu, Wei He, Sile Yu, Emmanuel Eric Pazo, Xingru He

Published in: Trials | Issue 1/2023

Abstract

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 fewer tear secretions than healthy individuals. While several anti-inflammatory drug-based therapies for dry eye in diabetic individuals are currently being administered, their efficacy has 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 dry eye patients.

Methods

This triple-blind randomized, control trial will include 202 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, conjunctivocorneal staining score, corneal sensitivity, tear MMP-9 levels, meibomian gland expression and quality, tear meniscus height, corneal nerves, immune/inflammatory cell change, conjunctival hyperemia, and 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 dry eye treatment.

Trial registration

ClinicalTrials.govNCT05682547. Registered on December 05, 2022.

Available only for authorised users

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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
Authors: Jiayan Chen
Yimeng Chen
Guanghao Qin
Liangzhe Li
Mingze Li
Yuan Cheng
Shuting Zhuang
Zhihui Li
Qing Zhang
Yi Wu
Lanting Yang
Salissou Moutari
Jonathan E. Moore
Ling Xu
Wei He
Sile Yu
Emmanuel Eric Pazo
Xingru He
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Xerophthalmia
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07818-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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