Keratitis
Conditions
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.
Interventions
DRUG1mg/mL ciclosporin
IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment
Sponsors
Santen SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient eligibility is determined according to the following criteria: 1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. 2. The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures 3. Male or female patient is aged 18 years or above. 4. 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 5. Patient must be willing and able to undergo and return for scheduled study-related examinations. 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3. | at month 3 | Spearman's coefficient of correlation will be calculated at Month 3 between the change from baseline of Corneal Fluorescein Staining (CFS) and respectively the change from baseline of Visual Maintenance Ratio (VRM). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IKERVIS® (1mg/mL Ciclosporin) Eye Drops one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.
1mg/mL ciclosporin: IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | — |
|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 12.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 17 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 9 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3.
Spearman's coefficient of correlation will be calculated at Month 3 between the change from baseline of Corneal Fluorescein Staining (CFS) and respectively the change from baseline of Visual Maintenance Ratio (VRM).
Time frame: at month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IKERVIS® (1mg/mL Ciclosporin) Eye Drops | Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3. | -0.7028 Spearman's coefficient of correlation |