3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

Summary

The proposed 36-month Post Approval Efficacy Study (PAES) is a prospective, interventional, multicentre study to explore the long-term evolution of signs and symptoms, and occurrence of complications in Dry Eye Disease (DED) patients with severe keratitis receiving Ikervis® (1mg/mL ciclosporin) eye drops administered once daily

Timeline

Start

2019-05-31

Primary completion

2023-07-14

Completion

2023-07-14

Publications

• Leonardi A, Aragona P, Sainz de la Maza M, Seleznev A, Wylegala E, Villani E, Baudouin C; Study Investigators. Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis. Ophthalmol Ther. 2026 Jul;15(7):2413-2429. doi: 10.1007/s40123-026-01411-3. Epub 2026 Jun 12.

Drugs

Indications