Trial reportEuropean journal of ophthalmology2017
One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease.
Trial report in European journal of ophthalmology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.
- Topical cyclosporine A therapy for dry eye syndrome.The Cochrane database of systematic reviews · 2019Pooled it
- Multi-Frequency RF Combined with Intense Pulsed Light Improves Signs and Symptoms of Dry Eye Disease Due to Meibomian Gland Dysfunction.Clinical ophthalmology (Auckland, N.Z.) · 2023Trial
- Cyclosporine A (0.05%) Ophthalmic Gel in the Treatment of Dry Eye Disease: A Multicenter, Randomized, Double-Masked, Phase III, COSMO Trial.Drug design, development and therapy · 2022Trial
- Intense pulsed light improves signs and symptoms of dry eye disease due to meibomian gland dysfunction: A randomized controlled study.PloS one · 2022Trial
- Efficacy and safety of 0.1% ciclosporin A cationic emulsion in dry eye disease: a pooled analysis of two double-masked, randomised, vehicle-controlled phase III clinical studies.The British journal of ophthalmology · 2019Trial
- 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
- Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis.Ophthalmology and therapy · 2026Article
- Long-Term Efficacy and Safety of 0.1% Cyclosporine A Cationic Emulsion in Advanced Dry Eye Disease: A 24-Month Retrospective Study.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Assessment the Safety of CyclASol compared with Vehicle and Commercially Available 0.05% Cyclosporine in Dry Eye Disease: A Systematic Review and Meta-analysis.Ophthalmology and therapy · 2025Article
- Effectiveness of 0.1% Cyclosporine a Cationic Emulsion for Treating Dry Eye Disease After Cataract Surgery Analyzed Using a Placido Tear Film Analyzer.Diagnostics (Basel, Switzerland) · 2025Article
- 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
- Improvement in signs and symptoms of severe dry eye disease after dual therapy with high-potency steroids and 0.05% cyclosporine.Annals of medicine · 2024Article
- 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
- Recent Advances in Nanotechnology for the Treatment of Dry Eye Disease.Nanomaterials (Basel, Switzerland) · 2024Review
- [Corneal wound healing-Pharmacological treatment].Die Ophthalmologie · 2024Article
- Clinical Outcomes of Topical 0.1% Ciclosporin Cationic Emulsion Used on Label in Children with Vernal Keratoconjunctivitis.Ophthalmology and therapy · 2023Article
- Management of inflammation in dry eye disease: Recommendations from a European panel of experts.European journal of ophthalmology · 2023Review
- Role of topical and systemic immunosuppression in aqueous-deficient dry eye disease.Indian journal of ophthalmology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE).
methodsIn this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis
resultsA total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA.
conclusionsIn this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.