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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Keratitis

Intervention / Treatment
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* Drug: 1mg/mL ciclosporin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligibility is determined according to the following criteria: In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures Male or female patient is aged 18 years or above. DED patients with persistent severe keratitis at the Screening and Baseline Visits defined as the following: • CFS score of 3, 4 or 5 on the modified Oxford scale Patient must be willing and able to undergo and return for scheduled study-related examinations. The same eye (eligible eye) should fulfill all the above criteria. Exclusion Criteria: Patients with history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Screening Visit and any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IKERVIS® (1mg/mL ciclosporin) eye drops<br>one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months. | Drug: 1mg/mL ciclosporin<br>* IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment<br>* Other names: IKERVIS®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the change from baseline in quality of vision and the change from baseline in Corneal Fluorescein Staining (CFS) | CFS test can detect damage to the cornea. | at month 3 |