Abstract
Introduction
This study aimed to investigate the tolerability of high-viscosity diquafosol tetrasodium (DQS) ophthalmic solution (DIQUAS LX; DQSLX) and examine its usability and effect on clinical findings in patients with dry eye disease (DED).
Methods
This interventional retrospective study included 66 eyes of 66 patients with DED who switched from conventional DQS to DQSLX ophthalmic solution. Tear function assessments (tear film breakup time [BUT], keratoconjunctival vital staining [VS] score), evaluations of DED symptom relief, and a four-item usability questionnaire (“comfort upon instillation,” “irritation upon instillation,” “eye mucus discharge,” “convenience of instillation frequency”) assessed using a visual analog scale from 0 (worst) to 10 (best) were administered 4 weeks after switching to DQSLX. Factors associated with drug tolerability were assessed using multiple regression analysis.
Results
The symptoms improved by 64.2% after switching to DQSLX. The BUT value, VS score, and the questionnaire items “comfort upon instillation” and “convenience of instillation frequency” were significantly improved after switching to DQSLX. DQSLX tolerability was reported as acceptable in 56 (84.8%) and unacceptable in 10 (15.2%) patients. Overall, DQSLX tolerability was significantly associated with “comfort upon instillation” and “convenience of instillation frequency” and tended to be associated with a VS score ≥ 1. DQSLX tolerability depended on symptom and VS score improvements and absence of excessive “eye mucus discharge” in patients with a VS score ≥ 1 (39 patients), but on “comfort upon instillation” and absence of excessive “eye mucus discharge” in patients with a VS score = 0 (27 patients).
Conclusion
The high-viscosity DQSLX ophthalmic solution was generally considered acceptable in the study population. However, drug tolerability seemingly differed between patients with DED with and without epithelial damage. The former were affected by improvements in symptoms and clinical findings, whereas the latter were affected by comfort upon instillation.
Trial Registration
University Hospital Medical Information Network identifier, UMIN000051390.
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English language editing, funded by the authors, was provided by Editage (http://www.editage.jp).
Funding
This study did not receive any specific grants from funding agencies in the public, commercial, or not-for-profit sectors. The journal’s Rapid Service Fee will be funded by the authors.
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Contributions
Conception and design of the study: Minako Kaido. Analysis and interpretation of results: Minako Kaido. Manuscript preparation: Minako Kaido. Critical review of the article: Reiko Arita. Data acquisition: Minako Kaido. Provision of materials, patients, or resources: Minako Kaido. Statistical expertise, literature searches: Minako Kaido. Administrative, technical, or logistic support: Minako Kaido, Reiko Arita.
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Conflict of Interest
Santen Pharmaceutical Co., Ltd (Osaka, Japan) was not involved in the scientific content of the research project or the writing of the manuscript. Minako Kaido and Reiko Arita declare that they have no competing interests.
Ethical Approval
The study protocol was reviewed and approved by the Ethics Committee of the Institutional Review Board of the Itoh Clinic, Saitama, Japan (Registry ID: 2022-1205). All procedures were performed in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all participants. This study was registered with the University Hospital Medical Information Network (Registry ID: UMIN000051390).
Data Availability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Kaido, M., Arita, R. Effects of a Long-Acting Diquafosol Ophthalmic Solution on the Ocular Surface, Tolerability, and Usability in Dry Eye Disease. Adv Ther (2024). https://doi.org/10.1007/s12325-024-02871-4
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DOI: https://doi.org/10.1007/s12325-024-02871-4