Clinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter study
Abstract Purpose To assess the clinical efficacy of 0.1% cyclosporine A (CsA) in dry eye patients who have shown inadequate responses to previous treatment with 0.05% CsA. Design This study was designed as a switching, prospective, multicenter, 12-week, open-label study. Methods Patients with dry ey...
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2025-01-01
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| Series: | BMC Ophthalmology |
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| Online Access: | https://doi.org/10.1186/s12886-025-03862-x |
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| author | Sook Hyun Yoon Eun Chul Kim In-Cheon You Chul Young Choi Jae Yong Kim Jong Suk Song Joon Young Hyon Hong Kyun Kim Kyoung Yul Seo |
| author_facet | Sook Hyun Yoon Eun Chul Kim In-Cheon You Chul Young Choi Jae Yong Kim Jong Suk Song Joon Young Hyon Hong Kyun Kim Kyoung Yul Seo |
| author_sort | Sook Hyun Yoon |
| collection | DOAJ |
| description | Abstract Purpose To assess the clinical efficacy of 0.1% cyclosporine A (CsA) in dry eye patients who have shown inadequate responses to previous treatment with 0.05% CsA. Design This study was designed as a switching, prospective, multicenter, 12-week, open-label study. Methods Patients with dry eye disease (DED), who experienced inadequate responses to at least 3 months of treatment with 0.05% cyclosporine, were enrolled in this study. Clinical evaluations included the National Eye Institute (NEI) corneal and conjunctival staining scores, tear film break-up time (TF-BUT), Symptom Assessment in Dry Eye (SANDE), ocular discomfort scale (ODS), and tear volume. These parameters were assessed at baseline, and again at 4, 8, and 12 weeks after switching to 0.1% CsA. Results Ninety-one patients were enrolled in the study, and 70 patients completed the trial. Statistical analysis was performed on the full analysis set (FAS) using the Markov Chain Monte Carlo (MCMC) method to account for missing data. After switching to 0.1% CsA, subjective symptoms assessed by the Symptom Assessment in Dry Eye (SANDE) and Ocular Discomfort Scale (ODS) showed improvement (p < 0.0001). Objective signs of dry eye, including the National Eye Institute (NEI) score, tear film break-up time (TF-BUT), and tear volume also improved (p < 0.0001). Conclusions In patients with dry eye disease (DED) who exhibited inadequate responses to 0.05% cyclosporine A (CsA), switching to 0.1% CsA resulted in significant improvements in both subjective symptoms and objective clinical signs. This finding suggests that higher concentrations of CsA may be more effective in treating individuals with moderate to severe DED. |
| format | Article |
| id | doaj-art-f39e75ebcf394517a4ab51e914ab3384 |
| institution | Kabale University |
| issn | 1471-2415 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Ophthalmology |
| spelling | doaj-art-f39e75ebcf394517a4ab51e914ab33842025-01-26T12:21:10ZengBMCBMC Ophthalmology1471-24152025-01-0125111210.1186/s12886-025-03862-xClinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter studySook Hyun Yoon0Eun Chul Kim1In-Cheon You2Chul Young Choi3Jae Yong Kim4Jong Suk Song5Joon Young Hyon6Hong Kyun Kim7Kyoung Yul Seo8Department of Ophthalmology, Daegu Catholic University of MedicineDepartment of Ophthalmology, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Ophthalmology, Jeonbuk National University Medical SchoolDepartment of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of MedicineDepartment of Ophthalmology, Seoul Asan Medical Center, University of Ulsan College of MedicineDepartment of Ophthalmology, Korea University College of MedicineDepartment of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of MedicineDepartment of Ophthalmology, School of Medicine, Kyungpook National UniversityInstitute of Vision Research, Department of Ophthalmology, Yonsei University College of MedicineAbstract Purpose To assess the clinical efficacy of 0.1% cyclosporine A (CsA) in dry eye patients who have shown inadequate responses to previous treatment with 0.05% CsA. Design This study was designed as a switching, prospective, multicenter, 12-week, open-label study. Methods Patients with dry eye disease (DED), who experienced inadequate responses to at least 3 months of treatment with 0.05% cyclosporine, were enrolled in this study. Clinical evaluations included the National Eye Institute (NEI) corneal and conjunctival staining scores, tear film break-up time (TF-BUT), Symptom Assessment in Dry Eye (SANDE), ocular discomfort scale (ODS), and tear volume. These parameters were assessed at baseline, and again at 4, 8, and 12 weeks after switching to 0.1% CsA. Results Ninety-one patients were enrolled in the study, and 70 patients completed the trial. Statistical analysis was performed on the full analysis set (FAS) using the Markov Chain Monte Carlo (MCMC) method to account for missing data. After switching to 0.1% CsA, subjective symptoms assessed by the Symptom Assessment in Dry Eye (SANDE) and Ocular Discomfort Scale (ODS) showed improvement (p < 0.0001). Objective signs of dry eye, including the National Eye Institute (NEI) score, tear film break-up time (TF-BUT), and tear volume also improved (p < 0.0001). Conclusions In patients with dry eye disease (DED) who exhibited inadequate responses to 0.05% cyclosporine A (CsA), switching to 0.1% CsA resulted in significant improvements in both subjective symptoms and objective clinical signs. This finding suggests that higher concentrations of CsA may be more effective in treating individuals with moderate to severe DED.https://doi.org/10.1186/s12886-025-03862-xDry eye diseaseCyclosporine ACationic emulsionSwitchingMulticenter study |
| spellingShingle | Sook Hyun Yoon Eun Chul Kim In-Cheon You Chul Young Choi Jae Yong Kim Jong Suk Song Joon Young Hyon Hong Kyun Kim Kyoung Yul Seo Clinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter study BMC Ophthalmology Dry eye disease Cyclosporine A Cationic emulsion Switching Multicenter study |
| title | Clinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter study |
| title_full | Clinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter study |
| title_fullStr | Clinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter study |
| title_full_unstemmed | Clinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter study |
| title_short | Clinical efficacy of 0.1% cyclosporine A in dry eye patients with inadequate responses to 0.05% cyclosporine A: a switching, prospective, open-label, multicenter study |
| title_sort | clinical efficacy of 0 1 cyclosporine a in dry eye patients with inadequate responses to 0 05 cyclosporine a a switching prospective open label multicenter study |
| topic | Dry eye disease Cyclosporine A Cationic emulsion Switching Multicenter study |
| url | https://doi.org/10.1186/s12886-025-03862-x |
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