ArticleClinical ophthalmology (Auckland, N.Z.)2018
Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program.
Article in Clinical ophthalmology (Auckland, N.Z.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- Corneal lymphangiogenesis as a potential target in dry eye disease - a systematic review.Survey of ophthalmologyPooled it
- The effect of 0.1% topical ciclosporin a for 12-weeks on the ocular surface innate and adaptive immune response in dry eye disease: protocol for a randomized controlled clinical trial.Annals of medicine · 2026Article
- 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 · 2025Article
- Reduced Ocular Surface Inflammation in SMILE Patients: The Beneficial Outcome of 0.1% Ciclosporin Cationic Emulsion Treatment.Clinical ophthalmology (Auckland, N.Z.) · 2025Article
- Real-world insights and outcomes related to ciclosporin A 0.1% cationic emulsion for the long-term treatment of dry eye disease in Germany: Country-level sub-analysis of the PERSPECTIVE study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024Observational
- Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment.Ophthalmology and therapy · 2024Article
- Management of inflammation in dry eye disease: Recommendations from a European panel of experts.European journal of ophthalmology · 2023Review
- Impact of Attrition, Intercellular Shear in Dry Eye Disease: When Cells are Challenged and Neurons are Triggered.International journal of molecular sciences · 2020Review
- Assessment of the efficacy of 0.1% cyclosporine A cationic emulsion in the treatment of dry eye disease during COVID-19 pandemic.Romanian journal of ophthalmologyObservational
- Efficacy and safety of topical cyclosporine 0.1% in moderate-to-severe dry eye disease refractory to topical cyclosporine 0.05% regimen.Taiwan journal of ophthalmologyArticle
Corrections and comments
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Authors and funding
8 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe objective of this study was to report the evaluation of efficacy and safety of cyclosporine A cationic emulsion (CsA CE) 0.1% for the treatment of severe keratitis in adults with dry eye disease (DED) in a French early-access program.
methodsPatients with DED and severe keratitis (corneal fluorescein staining [CFS] score of 3-5 on the Oxford scale and/or the presence of corneal lesions [filaments or ulcers]) were enrolled in a compassionate use program (Authorization for Temporary Use [ATU]) for once-daily CsA CE, which was approved by French health authorities prior to its registration. Efficacy and safety at 1, 3, 6, and 12-month follow-up visits were evaluated.
resultsThe ATU cohort (n=1,212; mean age =60.5 years; 79.5% female; 98.1% with severe keratitis; 74.5% with corneal lesions) consisted of 601 CsA-naïve patients and 611 patients treated previously with other CsA formulations. The primary DED etiology was Sjögren's syndrome (48.7%). Clinical benefit could be discerned among 548 evaluable patients from months 1 to 12: keratitis improvement, 44.8% at month 1 and 42.1% at month 12; keratitis stabilization, 47.2% and 45.7%, respectively; symptom improvement, 47.2% and 48.6%; and symptom stabilization, 44.8% and 45.0%. Corneal clearing (CFS score =0) increased from 4.8% (month 1) to 11.4% (month 12). No unexpected safety concerns were identified; instillation site pain (10.2%) and eye irritation (7.8%) were the most common adverse events.
conclusionThe French ATU cohort provides supportive data on the clinical benefit of CsA CE in improving/stabilizing symptoms and corneal damage in DED patients with severe keratitis in real-world clinical practice.
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