Back to resultsEffect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
Primary Purpose
Keratitis
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
1mg/mL ciclosporin
Sponsored by
About this trial
This is an interventional treatment trial for Keratitis
Eligibility Criteria
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.
Sites / Locations
- CHU de BrestRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IKERVIS® (1mg/mL ciclosporin) eye drops
Arm Description
one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03237936
Brief Title
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen SAS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IKERVIS® (1mg/mL ciclosporin) eye drops
Arm Type
Experimental
Arm Description
one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.
Intervention Type
Drug
Intervention Name(s)
1mg/mL ciclosporin
Other Intervention Name(s)
IKERVIS®
Intervention Description
IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment
Primary Outcome Measure Information:
Title
Correlation between the change from baseline in quality of vision and the change from baseline in Corneal Fluorescein Staining (CFS)
Description
CFS test can detect damage to the cornea.
Time Frame
at month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elsa LLOBET-MERKLING
Phone
0613861174
Email
e.llobetmerkling@euraxipharma.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Jean PISELLA
Organizational Affiliation
CHU Bretonneau
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Béatrice COCHENER, MD
First Name & Middle Initial & Last Name & Degree
Pierre-Jean PISELLA, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
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