Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis

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2026年6月12日

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Andrea Leonardi,
Pasquale Aragona,
Maite Sainz de la Maza,
Aleksei Seleznev,
Edward Wylegala,
Edoardo Villani,
Christophe Baudouin,
Ivana Liehneova,
Vladimir Korda,
Jana Nekolova,
Petr Masek,
Ales Cech,
Daniela Rybarova,
Tatana Laboha,
Paolo Fogagnolo,
Stefano Barabino,
Francesco Viola,
Malgorzata Siewierska,
Tomasz Zarnowski,
Ewa Mrukwa-Kominek,
Piotr Fryczkowski,
Marta Misiuk-Hojlo,
Sergey Astakhov,
Natalya Gavrilova,
Ekaterina Gornostaeva,
Aleksei Seleznev,
Nadezhda Pozdeeva,
Arturo Ruiz Vargas,
Cristina Peris-Martinez,
Javier Mendicute,
Jesus Montero,
Isabel Pinilla Lozano,
Jose Lamarca Mateu,
Banu Bozkurt Alptekin,
Omur Gunduz,
Melis Palamar

摘要

Introduction

A 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).

Methods

Adult 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.

Results

Overall, 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.

Conclusions

Once-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.