NCT04492878

Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

A Phase IV Open-Label Clinical Trial to Evaluate the Efficacy of Ikervis® on Clinical Parameters and Molecular/Cellular Biomarkers in Dry Eye Patients With Severe Keratitis Who Have Not Improved Despite Regular Use of Tear Substitutes Before and After Exposure to an Adverse Controlled Environment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye
• Dry Eye Syndromes
• Severe Keratitis

Interventions

Type	Name	Description
DRUG	IKERVIS®1mg/mL	One drop of study medication once daily in each eye at bedtime during 90 days.

Timeline

• Start date: 2020-02-04
• Primary completion: 2021-01-18
• Completion: 2021-01-18
• First posted: 2020-07-30
• Last updated: 2021-04-21

Locations

1 site across 1 country: Spain