Study identification

PURI

https://redirect.ema.europa.eu/resource/36178

EU PAS number

EUPAS22376

Study ID

36178

Official title and acronym

Cyclosporine 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.

DARWIN EU® study

No

Study countries

Finland
Germany
Norway
Sweden
United Kingdom

Study description

This is a prospective, non-interventional study of the effectiveness, tolerability and safety of Ikervis® in the targeted population as defined in section 1.6 of the SPC, in a real world setting

Study status

Ongoing
Research institutions and networks

Institutions

Augenklinik
Hyks silmaklinikka Helsinki, Paijat-Hameen Keskussairaala (PHKS) (Paijat-Hame Central Hospital) Lahti, Augenklinik des Universitatsklinikums Wurzburg Wurzburg, Chiemsee Augentagesklinik Prien, Augenklinik des Universitatsklinikums Magdeburg Magdeburg, Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes Homburg, MVZ Schweinfurt Schweinfurt, Universitats-Augenklinik Freiburg Freiburg, Universitatsklinikums Hamburg Eppendorf Hamburg, Augenklinik des Universitatsklinikums Tubingen Tubingen

Contact details

Manfred Zierhut

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

SANTEN
Study protocol
Initial protocol

IKERVIS Protocol

English (753.34 KB - PDF)View document
Updated protocol

Amended Protocol V3_04Apr2018_ Clean_ Eng_Final

English (863.47 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable