Phase 4
N=17
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
Keratitis
Bottom Line
View on ClinicalTrials.gov: NCT03237936 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: 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. — -0.7028 Spearman's coefficient of correlation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 1mg/mL ciclosporin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Santen SAS
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-0.7028 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03237936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.