Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

Summary

The proposed study is a prospective, open-label, unicentric, phase IV clinical trial. This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Additionally, this study intends to investigate whether IKERVIS® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ACE) and analyzing both clinical and molecular parameters.

Timeline

Start

2020-02-04

Primary completion

2021-01-18

Completion

2021-01-18

Publications

• Valencia-Nieto L, Pinto-Fraga J, Blanco-Vazquez M, Fernandez I, Lopez-Miguel A, Garcia-Vazquez C, Gonzalez-Garcia MJ, Enriquez-de-Salamanca A, Calonge M. Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment. Ophthalmol Ther. 2024 May;13(5):1197-1210. doi: 10.1007/s40123-024-00906-1. Epub 2024 Mar 6.

Drugs

Indications