Trial reportEuropean journal of ophthalmology2017
A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye.
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 45 papers, 4 of them syntheses 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
45 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Evidence on the Use of Topical Ciclosporin for Ocular Surface Disease: A Systematic Review and Meta-Analysis.Clinical & experimental ophthalmology · 2025Pooled it
- Comparison of seven cyclosporine A formulations for dry eye disease: A systematic review and network meta-analysis.Frontiers in pharmacology · 2022Pooled it
- An Updated Systematic Review With Meta-Analysis Of Randomized Trials On Topical Cyclosporin A For Dry-Eye Disease.Drug design, development and therapy · 2020Pooled it
- Topical cyclosporine A therapy for dry eye syndrome.The Cochrane database of systematic reviews · 2019Pooled it
- Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation.BMC ophthalmology · 2024Trial
- Trial
- A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease.Ophthalmology · 2019Trial
- 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
- Trial
- One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease.European journal of ophthalmology · 2017Trial
- 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
- Water-Free Cyclosporine 0.1% in Dry Eye Disease: Formulation Rationale, Clinical Evidence, and Unresolved Questions.Drug design, development and therapy · 2026Review
- Comparative Efficacy of Cyclosporine, Tacrolimus, and Neurostimulatory Nasal Sprays for Moderate-to-Severe Dry Eye Disease: A Systematic Review and Network Meta-Analysis.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
- The Safety and Tolerability of a Single Scleral Treatment With a Cooling Device in Rabbits.Translational vision science & technology · 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
- Corticosteroid-sparing topical treatment with cyclosporin for juvenile keratoconjunctivitis.Scientific reports · 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
- 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe SICCANOVE study aimed to compare the efficacy and safety of 0.1% cyclosporine A cationic emulsion (CsA CE) versus vehicle in patients with moderate to severe dry eye disease (DED).
methodsIn this multicenter, double-masked, parallel-group, controlled study, patients were randomized (1:1) to receive CsA CE (Ikervis®) or vehicle for 6 months. The co-primary efficacy endpoints at month 6 were mean change from baseline in corneal fluorescein staining (CFS; modified Oxford scale) and in global ocular discomfort (visual analogue scale [VAS]).
resultsThe mean change in CFS from baseline to month 6 (CsA CE: n = 241; vehicle: n = 248) was significantly greater with CsA CE than with vehicle (-1.05 ± 0.98 and -0.82 ± 0.94, respectively; p = 0.009). Ocular discomfort improved similarly in both groups; however, the percentage of patients with ≥25% improvement in VAS was significantly higher with CsA CE (50.2%) than with vehicle (41.9%; p = 0.048). In a post hoc analysis of patients with severe ocular surface damage (CFS score 4) at baseline (CsA CE: n = 43; vehicle: n = 42), the percentage of patients with improvements of ≥2 grades in CFS score and ≥30% in Ocular Surface Disease Index score was significantly greater with CsA CE (p = 0.003). Treatment compliance and ocular tolerability were satisfactory and as expected for CsA use.
conclusionCyclosporine A CE was well-tolerated and effectively improved signs and symptoms in patients with moderate to severe DED over 6 months, especially in patients with severe disease, who are at risk of irreversible corneal damage.
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Registered trials
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.