Emmanuel Eric Pazo

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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 Edward Moore, Ling Xu, Wei He, Sile Yu, Emmanuel Eric Pazo, Xingru He

Trials, 2023 · article · doi:10.1186/s13063-023-07818-8 · cited by 2 · Open access (CC BY)

Ocular surface & dry eye

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.

Keywords: diquafosol; hyaluronic acid; eye drops; tear film; meibomian glands; corneal nerves; MMP-9; tear film break-up time

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How to cite

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. https://doi.org/10.1186/s13063-023-07818-8

@article{chen2023a,
  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}},
  author = {Chen, Jiayan and Chen, Yimeng and Qin, Guanghao and Li, Liangzhe and Li, Mingze and Cheng, Yuan and Zhuang, Shuting and Li, Zhihui and Zhang, Qing and Wu, Yi and Yang, Lanting and Moutari, Salissou and Moore, Jonathan Edward and Xu, Ling and He, Wei and Yu, Sile and Pazo, Emmanuel Eric and He, Xingru},
  journal = {Trials},
  year = {2023},
  doi = {10.1186/s13063-023-07818-8},
  url = {https://doi.org/10.1186/s13063-023-07818-8},
}

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