Trial Outcomes & Findings for Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis (NCT NCT03237936)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

at month 3

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IKERVIS® (1mg/mL Ciclosporin) Eye Drops n=17 Participants 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
Age, Continuous	61.9 years STANDARD_DEVIATION 12.7 • n=17 Participants
Sex: Female, Male Female	13 Participants n=17 Participants
Sex: Female, Male Male	4 Participants n=17 Participants
Region of Enrollment France	17 participants n=17 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	IKERVIS® (1mg/mL Ciclosporin) Eye Drops n=17 Participants 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
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 Interval -0.8797 to -0.3158

Adverse Events

IKERVIS® (1mg/mL Ciclosporin) Eye Drops

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IKERVIS® (1mg/mL Ciclosporin) Eye Drops n=17 participants at risk 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
Eye disorders EYE IRRITATION	17.6% 3/17 • Adverse events were collected from the time of informed consent until the subject's participation in the study ended at Month 3. Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication.
Eye disorders DRY EYE	11.8% 2/17 • Adverse events were collected from the time of informed consent until the subject's participation in the study ended at Month 3. Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication.
Eye disorders EYE BURNS	5.9% 1/17 • Adverse events were collected from the time of informed consent until the subject's participation in the study ended at Month 3. Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication.
Eye disorders EYELID OEDEMA	5.9% 1/17 • Adverse events were collected from the time of informed consent until the subject's participation in the study ended at Month 3. Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication.
Eye disorders PHOTOPHOBIA	5.9% 1/17 • Adverse events were collected from the time of informed consent until the subject's participation in the study ended at Month 3. Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication.
Eye disorders VISUAL ACUITY REDUCED	5.9% 1/17 • Adverse events were collected from the time of informed consent until the subject's participation in the study ended at Month 3. Adverse events (AEs) are presented for the Safety analysis population. AEs were defined as any untoward medical occurrence in the study irrespective of a causal relationship with the study medication.

Additional Information

R&D Quality Manager

Santen Inc

Phone: 4152689199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place