Ciclosporin eye drop emulsion for treatment of dry eye condition
Research type
Research Study
Full title
Ciclosporin 1mg/ml eye drop emulsion (Ikervis®) for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes: Clinical effectiveness, tolerability and safety in a real world setting
IRAS ID
219953
Contact name
Ejaz Ansari
Contact email
Sponsor organisation
Santen GmbH
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is an obervational study, done with the purpose to collect information about how effective is a drug, in controlling severe keratitis in dry eye condition, which is an inflammation of the front part of the eye (cornea).
The drug is called Ikervis® (Ciclosporin 1mg/ml eye drop emulsion) and it is already available on prescription, in United Kingdom. The patients recruited for this study are those who had not improved despite treatment with tear substitues and had not used this drug before. The study will collect data on maximum 5 visits if the visit time fits to the study time frames of 4, 12 and 24 weeks and 12 months after the initial treatment with Ikervis®. The study will also measure how the patients feel when using Ikervis®, the tear production in their eye(s), the redness of the eyelid and of the part of the eye underlying the eyelid covering the white of the eye.
Furthermore, the study aims to gain information on the reduction in use of artificial tears and steroids.
The study related data will be collected during patients routine visits to the treating doctor. No additional visits or treatments will be performed solely for this study.
This study will enroll about 1630 patients in 5 countries.REC name
West of Scotland REC 4
REC reference
17/WS/0146
Date of REC Opinion
14 Aug 2017
REC opinion
Further Information Favourable Opinion