A Phase 4 interventional study of 1mg/mL ciclosporin in Keratitis, sponsored by Santen SAS. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Santen SAS (part of Santen Pharmaceutical Co., Ltd.) · Phase 4, Interventional, and Treatment
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.
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.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 17 is below the median of 40 across 70 interventional studies indexed under Keratitis.
Browse Keratitis studies →Santen SAS is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
First submitted after Santen Inc. became part of Santen Pharmaceutical Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient eligibility is determined according to the following criteria:
DED patients with persistent severe keratitis at the Screening and
Baseline Visits defined as the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.
Drug: 1mg/mL ciclosporin
IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment
Also known as: IKERVIS®
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
| Milestone | IKERVIS® (1mg/mL Ciclosporin) Eye Drops |
|---|---|
| Started | 17 |
| Completed | 16 |
| Not completed | 1 |
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).
| Spearman's coefficient of correlation | 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 (-0.8797 to -0.3158) |
Collected over Adverse events were collected from the time of informed consent until the subject's participation in the study ended at Month 3.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 0/17 (0%) | 0/17 (0%) | 9/17 (52.9%) |
| Event | IKERVIS® (1mg/mL Ciclosporin) Eye Drops |
|---|---|
| EYE IRRITATIONEye disorders | 3/17 |
| DRY EYEEye disorders | 2/17 |
| EYE BURNSEye disorders | 1/17 |
| EYELID OEDEMAEye disorders | 1/17 |
| PHOTOPHOBIAEye disorders | 1/17 |
| VISUAL ACUITY REDUCEDEye disorders | 1/17 |
| Age, Continuous(years) | IKERVIS® (1mg/mL Ciclosporin) Eye Drops |
|---|---|
| Mean | 61.9 ± 12.7 |
| Sex: Female, Male(Participants) | IKERVIS® (1mg/mL Ciclosporin) Eye Drops |
|---|---|
| Female | 13 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | IKERVIS® (1mg/mL Ciclosporin) Eye Drops |
|---|
| Region of Enrollment(participants) | IKERVIS® (1mg/mL Ciclosporin) Eye Drops |
|---|---|
| France | 17 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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