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.

Abstract

BACKGROUND/AIM:

To assess the treatment effect of 0.1% ciclosporin A cationic emulsion (CsA CE) versus vehicle on signs/symptoms of dry eye disease (DED) in various subgroups (moderate-to-severe DED/severe DED/Sjögren's syndrome (SS)/SS with severe DED).

METHODS:

Pooled data were analysed from two similar phase III studies: SICCANOVE (moderate-to-severe DED) and SANSIKA (severe DED with severe keratitis). In both studies, patients aged ≥18 years received CsA CE 0.1% (n=395) or vehicle (n=339) once daily for 6 months. A composite responder efficacy endpoint (corneal fluorescein staining-Ocular Surface Disease Index (CFS-OSDI) at month 6) was used to evaluate the efficacy of CsA CE in alleviating signs/symptoms of DED (response defined as improvement of ≥2 grades in CFS and ≥30% in OSDI (baseline to month 6)). Human leucocyte antigen-DR (HLA-DR) conjunctival expression was used as a biomarker of ocular surface inflammation.

RESULTS:

CsA CE-treated patients were significantly more likely to be CFS-OSDI responders than vehicle-treated patients in the overall (OR 1.66, 95% CI 1.11 to 2.50; P=0.015), severe DED (1.80, 1.04 to 3.19; P=0.038) and SS with severe DED (3.37, 1.20 to 11.19; P=0.030) populations. The difference was not significant for CsA CE versus vehicle for the overall Sjögren's population (OR 1.77, CI 0.89 to 3.66; P=0.109). CsA CE also significantly reduced median HLA-DR expression versus vehicle at 6 months (P=0.002).

CONCLUSION:

Pooled phase III data indicate CsA CE produced significant improvement in signs/symptoms versus vehicle in patients with moderate-to-severe DED (especially in those with severe keratitis), including patients with SS with severe DED.

• Authors: Andrea Leonardi, Elisabeth M Messmer, Marc Labetoulle, Mourad Amrane, Jean-Sébastien Garrigue, Dahlia Ismail, Maite Sainz-de-la-Maza, Francisco C Figueiredo, Christophe Baudouin
• Journal: The British journal of ophthalmology (Br J Ophthalmol) Vol. 103 Issue 1 Pg. 125-131 (01 2019) ISSN: 1468-2079 [Electronic] England
• PMID: 29545413 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Chemical References

• Immunosuppressive Agents
• Ophthalmic Solutions
• Cyclosporine

Topics

• Aged
• Cyclosporine (adverse effects, therapeutic use)
• Double-Blind Method
• Dry Eye Syndromes (drug therapy)
• Female
• Humans
• Immunosuppressive Agents (adverse effects, therapeutic use)
• Logistic Models
• Male
• Middle Aged
• Ophthalmic Solutions
• Visual Acuity