NCT03237936

Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis

A Phase IV, Prospective, Open-label, Multicentre, Single Arm, 3-month Proof of Concept Study to Assess the Effect of IKERVIS® Eye Drops Administered Once Daily on the Quality of Vision in Dry Eye Disease (DED) Patients With Severe Keratitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.

Detailed description

In this phase IV clinical trial the Month 3 visit assessments will be used to assess the efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with severe keratitis. To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3 months of treatment. To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL ciclosporin) for 3 months.

Conditions

• Keratitis

Interventions

Type	Name	Description
DRUG	1mg/mL ciclosporin	IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment

Timeline

• Start date: 2017-03-28
• Primary completion: 2018-07-11
• Completion: 2018-07-11
• First posted: 2017-08-03
• Last updated: 2024-04-18
• Results posted: 2024-04-18

Locations

1 site across 1 country: France