September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Pooling of two randomized Phase III clinical trials of ciclosporin 1 mg/mL cationic emulsion (CsA CE) as a treatment for severe keratitis in patients with dry eye disease (DED)
Author Affiliations & Notes
  • Elisabeth Messmer
    Department of Ophthalmology, Ludwig-Maximilian-University Munich, München, Germany
  • Andrea Leonardi
    Department of Neuroscience, Ophthalmology Unit, University of Padua , Padua, Italy
  • Mourad Amrane
    Santen SAS, Evry, France
  • Dahlia Ismail
    Santen SAS, Evry, France
  • Francisco C Figueiredo
    Royal Victoria Infirmary , Newcastle University, Newcastle upon Tyne, United Kingdom
  • Christophe Baudouin
    Quinze-Vingts National Ophthalmology Hospital, Paris, France
    UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, France
  • Footnotes
    Commercial Relationships   Elisabeth Messmer, Alcon Pharma GmbH (R), Croma Pharma (R), Dompé (C), Dompé (R), Farmigea (R), Oculus Optikgeräte GmbH (R), Pharm-Allergan GmbH (C), Pharm-Allergan GmbH (R), Santen GmbH (C), Santen GmbH (R), Thea Pharma GmbH (R), Ursapharm (R); Andrea Leonardi, Alcon (C), Allergan (C), Santen (C), Sifi (C), Thea (C); Mourad Amrane, Santen SAS (E); Dahlia Ismail, Santen SAS (E); Francisco Figueiredo, Santen (C), Thea (C); Christophe Baudouin, Alcon (C), Allergan (C), Santen (C), Thea (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2871. doi:
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      Elisabeth Messmer, Andrea Leonardi, Mourad Amrane, Dahlia Ismail, Francisco C Figueiredo, Christophe Baudouin; Pooling of two randomized Phase III clinical trials of ciclosporin 1 mg/mL cationic emulsion (CsA CE) as a treatment for severe keratitis in patients with dry eye disease (DED). Invest. Ophthalmol. Vis. Sci. 2016;57(12):2871.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Severe keratitis in DED increases risk of ocular surface damage, vision loss and impaired quality of life. Preclinical and clinical testing of once-daily CsA CE showed a positive benefit–risk ratio in the treatment of severe keratitis in patients with DED. The objectives of this analysis were to understand the magnitude of the treatment effect of CsA CE over vehicle (V) on signs and symptoms of DED in the overall DED population as well as in patients with severe keratitis and in patients with Sjögren’s syndrome.

Methods : A pooled analysis of efficacy data from the SANSIKA and SICCANOVE Phase III clinical trials in patients with moderate to severe DED was performed. 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 on signs and symptoms of DED.

Response was defined as improvement of ≥2 grades in CFS and ≥30% in OSDI. CFS-OSDI responder rate was analyzed in four different populations: combined full analysis set (FAS, n=734 patients with moderate to severe DED), severe FAS (n=319 patients with CFS Grade 4 on modified Oxford scale and OSDI ≥23), Sjögren’s FAS (n=269) and Sjögren’s severe FAS (n=130) using logistic regression.

Results : The CFS-OSDI responder rate (Table 1) was greater with CsA CE compared with V, with a statistically significant difference in both the FAS and severe FAS. The responder rate in Sjögren’s severe FAS at baseline was significantly higher with CsA CE compared with V, reflecting a three-times-greater probability of response (odds ratio 3.04 [1.13; 9.5]). Difference in responder rate was not statistically significant in the Sjögren’s FAS.

Conclusions : CsA CE demonstrates a significant benefit over V in improving signs and symptoms in patients with moderate to severe DED. Results were more pronounced in patients with severe keratitis. This result was also shown in patients with Sjögren’s syndrome and severe keratitis.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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