Ciclosporin A 0,05 % Augentropfen zur Therapie der Keratokonjunktivitis sicca

Zusammenfassung

Hintergrund: Eine Entzündung der Augenoberfläche wird in der Pathogenese der Keratokonjunktivitis sicca zunehmend als Schlüsselmechanismus angesehen. Ziel dieser Studie war die Evaluation der topischen Therapie mit Ciclosporin A 0,05 % AT.

Patienten und Methoden: In diese klinische Studie wurden 62 Patienten mit mittelschwerer bis schwerer Keratokonjunktivitis sicca (Schweregrad 3 nach DEWS-Kriterien) eingeschlossen. Alle Patienten erhielten über einen Zeitraum von 3 Monaten eine Lokaltherapie mit hyaluronsäurehaltigen Augentropfen 5 × /Tag und 31 Patienten wurden zusätzlich mit Ciclosporin A 0,05 % AT 2 × /Tag topisch behandelt. Ausgewertet wurden lidkantenparallele Konjunktivalfalten (LIPCOF), Tränenfilmaufreißzeit (Break-up-time BUT), Vitalfärbungen (Fluoreszein-, Bengalrosafärbung), Tränenbasissekretionstest (Jones-Test), Tensio und als subjektiver Parameter der Ocular Surface Disease Index (OSDI-Score).

Ergebnisse: BUT, Jones-Test und OSDI-Score verbesserten sich gegenüber den Ausgangswerten nach 3 Monaten signifikant in der Ciclosporin A-Gruppe im Gegensatz zur Kontrollgruppe. Auch im Gruppenvergleich zeigte die Ciclosporin A-Gruppe nach 3 Monaten signifikant höhere Werte in BUT und Jones-Test im Vergleich zur Kontrollgruppe. In den Vitalfärbungen ergab sich nur in der Ciclosporin A-Gruppe eine tendenzielle Verbesserung der Werte nach 3 Monaten.

Schlussfolgerung: Die Therapie des trockenen Auges kann durch antiinflammatorische Medikamente, wie Ciclosporin A mit dem kausalen Therapieansatz verbessert werden. Subjektive und objektive Parameter weisen im Verlauf eine deutliche Besserung bei gutem Sicherheitsprofil des Medikamentes auf. Da derzeit auf dem europäischen Markt ein entsprechendes Ciclosporin A-Fertigpräparat nicht verfügbar ist, sollen diese Untersuchungen einen Beitrag zur Verbesserung des Bekanntheitsgrades dieser antiinflammatorischen Therapieoption bei therapierefraktärer Keratokonjunktivitis sicca leisten.

Abstract

Background: The current understanding of the pathogenesis of dry eye disease has proceeded to recognition of inflammation as the key pathogenetic mechanism. The purpose of this study was to evaluate the effect of cyclosporine 0.05 % eye drops on subjective symptoms and objective signs of patients with keratoconjunctivitis sicca.

Patients and Methods: In this clinical trial 62 patients with severe keratoconjunctivitis sicca (DEWS grade 3) were included. Over a time period of 3 months all patients received treatment with preservative-free hyaluronic acid artificial tears at one drop 5 times per day and in addition 31 patients received one drop of cyclosporine 0.05 % twice daily. Screening parameters were LIPCOF, tear break-up time (BUT), fluorescein and rose bengal staining, the intraocular pressure (IOP) and the OSDI score.

Results: In the cyclosporine A group BUT, Jones test and OSDI score improved significantly after 3 months in contrast to the controls. Moreover the values of BUT and Jones test in the cyclosporine A group were significantly higher after 3 months compared to the healthy controls. Fluorescein and rose bengal staining improved only in the cyclosporine A group after 3 months.

Conclusion: Anti-inflammatory therapy with cyclosporine A 0.05 % eye drops as off label use significantly improves subjective symptoms and objective signs in patients with severe dry eye disease providing a good safety profile. These findings suggest a widespread use of cyclosporine A 0.05 % eye drops in patients with moderate to severe keratoconjunctivitis sicca.

Schlüsselwörter

Kornea - Bindehaut - trockenes Auge - Inflammation - Ciclosporin A - kausale Therapie

Key words

cornea - conjunctiva - dry eye - inflammation - cyclosporine A - causal therapy

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