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

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

doi:10.1186/s13063-023-07818-8

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

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

Mathematical Sciences Research Centre

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Abstract

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. 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. 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. ClinicalTrials.govNCT05682547. Registered on December 05, 2022.

Original language	English
Article number	803
Number of pages	12
Journal	Trials
Volume	24
Early online date	12 Dec 2023
DOIs	https://doi.org/10.1186/s13063-023-07818-8
Publication status	Early online date - 12 Dec 2023

Keywords

Treatment Outcome
Humans
Hyaluronic acid
Randomized Controlled Trials as Topic
Diabetic dry eye
Ophthalmic Solutions
Diabetes Mellitus
Dry eye disease
Hyaluronic Acid - adverse effects
Randomized controlled trial
Diquafosol
Dry Eye Syndromes - diagnosis - drug therapy - metabolism

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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A protocol for a single center, randomized, controlled trial comparing the clinical efcacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease
© 2023 The Authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 1.25 MBLicence: CC BY

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Chen, J., Chen, Y., Qin, G., Li, L., Li, M., Cheng, Y., Zhuang, S., Li, Z., Zhang, Q., Wu, Y., Yang, L., Moutari, S., Moore, J. E., Xu, L., He, W., Yu, S., Pazo, E. E., & He, X. (2023). 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. Trials, 24, Article 803. Advance online publication. https://doi.org/10.1186/s13063-023-07818-8

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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",

abstract = "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. 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. 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. ClinicalTrials.govNCT05682547. Registered on December 05, 2022. ",

keywords = "Treatment Outcome, Humans, Hyaluronic acid, Randomized Controlled Trials as Topic, Diabetic dry eye, Ophthalmic Solutions, Diabetes Mellitus, Dry eye disease, Hyaluronic Acid - adverse effects, Randomized controlled trial, Diquafosol, Dry Eye Syndromes - diagnosis - drug therapy - metabolism",

author = "Jiayan Chen and Yimeng Chen and Guanghao Qin and Liangzhe Li and Mingze Li and Yuan Cheng and Shuting Zhuang and Zhihui Li and Qing Zhang and Yi Wu and Lanting Yang and Salissou Moutari and Moore, {Jonathan E} and Ling Xu and Wei He and Sile Yu and Pazo, {Emmanuel Eric} and Xingru He",

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doi = "10.1186/s13063-023-07818-8",

language = "English",

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Chen, J, Chen, Y, Qin, G, Li, L, Li, M, Cheng, Y, Zhuang, S, Li, Z, Zhang, Q, Wu, Y, Yang, L, Moutari, S, Moore, JE, Xu, L, He, W, Yu, S, Pazo, EE & He, X 2023, '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', Trials, vol. 24, 803. https://doi.org/10.1186/s13063-023-07818-8

TY - JOUR

T1 - 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

AU - Chen, Jiayan

AU - Chen, Yimeng

AU - Qin, Guanghao

AU - Li, Liangzhe

AU - Li, Mingze

AU - Cheng, Yuan

AU - Zhuang, Shuting

AU - Li, Zhihui

AU - Zhang, Qing

AU - Wu, Yi

AU - Yang, Lanting

AU - Moutari, Salissou

AU - Moore, Jonathan E

AU - Xu, Ling

AU - He, Wei

AU - Yu, Sile

AU - Pazo, Emmanuel Eric

AU - He, Xingru

PY - 2023/12/12

Y1 - 2023/12/12

N2 - 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. 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. 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. ClinicalTrials.govNCT05682547. Registered on December 05, 2022.

AB - 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. 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. 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. ClinicalTrials.govNCT05682547. Registered on December 05, 2022.

KW - Treatment Outcome

KW - Humans

KW - Hyaluronic acid

KW - Randomized Controlled Trials as Topic

KW - Diabetic dry eye

KW - Ophthalmic Solutions

KW - Diabetes Mellitus

KW - Dry eye disease

KW - Hyaluronic Acid - adverse effects

KW - Randomized controlled trial

KW - Diquafosol

KW - Dry Eye Syndromes - diagnosis - drug therapy - metabolism

U2 - 10.1186/s13063-023-07818-8

DO - 10.1186/s13063-023-07818-8

M3 - Article

C2 - 38087329

SN - 1745-6215

VL - 24

JO - Trials

JF - Trials

M1 - 803

ER -

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

Keywords

UN SDGs

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