NCT04144413

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

A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dry Eye Disease With Severe Keratitis

Interventions

Type	Name	Description
DRUG	Open-label Ikervis	NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
DRUG	Masked Ikervis	NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
OTHER	Vehicle Comparator: Masked Vehicle	Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.

Timeline

• Start date: 2019-05-31
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2019-10-30
• Last updated: 2024-08-28
• Results posted: 2024-08-28

Locations

45 sites across 7 countries: Czechia, France, Italy, Poland, Russia, Spain, Turkey (Türkiye)