ArticleOphthalmology and therapy2026
Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis.
Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04144413 (A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis®), which is not on this map. Not yet cited in PubMed.
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.
A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionA 3-year multicenter trial was conducted to examine safety/tolerability and potential symptom relief delays following ocular sign improvement in patients with dry eye disease (DED) and severe keratitis using once-daily ciclosporin A (CsA) 0.1% cationic emulsion (CE).
methodsAdult patients with DED and corneal fluorescein staining (CFS) graded ≥ 3 (modified Oxford scale) received open-label CsA 0.1% CE for 12 months. Patients achieving ≥ 2-grade CFS reduction at month 12 were randomized 3:2 to CsA 0.1% CE or vehicle during months 12-36. Incidence and onset of ocular surface complications and adverse events (AEs) were reported. Spearman's correlation coefficient (SCC) calculations examined any relationship between CFS and symptom assessment in dry eye (SANDE) changes.
resultsOverall, 336 participants received open-label CsA 0.1% CE. Mean (standard deviation) age was 59.4 (13.4) years and the majority were female (86.0%) and white (94.6%). In total, 279 (83%) demonstrated ≥ 2-grade CFS reductions and 245 were randomized at month 12. Ocular complications (infections; 3-6-line visual acuity reduction) occurred in 3.2% (n = 11; CsA 0.1% CE; open-label period), 4.7% (n = 7; CsA 0.1% CE; randomized period), and 3.1% (n = 3; vehicle). Median onset was 5.9 (open-label period), 8.2 (CsA 0.1% CE; randomized period), and 6.3 months (vehicle). SCC values comparing month 3 CFS change with SANDE reductions at months 3, 6, 9, and 12 were 0.169, 0.245, 0.274, and 0.178, respectively, and indicated a 3-6-month delay in symptom improvement. Non-serious ocular treatment-related AEs occurred in 62 open-label participants and in 5 (CsA 0.1% CE) and 4 (vehicle) randomized patients.
conclusionsOnce-daily CsA 0.1% CE was well tolerated with low ocular surface complication rates through month 36 in adults with DED. Symptom relief may be delayed by 3-6 months following CFS improvement. CLINICAL TRIAL NUMBER: NCT04144413; EudraCT Number: 2017-002660-41.
Indexed as
Identifiers
What OpenQuestion holds
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.