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Clinical Trial Summary

The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.


Clinical Trial Description

In this phase IV clinical trial the Month 3 visit assessments will be used to assess the efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with severe keratitis.

To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3 months of treatment.

To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL ciclosporin) for 3 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03237936
Study type Interventional
Source Santen SAS
Contact Elsa LLOBET-MERKLING
Phone 0613861174
Email e.llobetmerkling@euraxipharma.fr
Status Recruiting
Phase Phase 4
Start date March 28, 2017
Completion date July 2018

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