Clinical Trial Results:
A PHASE IV, PROSPECTIVE, OPEN-LABEL, MULTICENTRE, SINGLE ARM, 3-MONTH PROOF OF CONCEPT STUDY TO ASSESS THE EFFECT OF IKERVIS® 1MG/ML (CICLOSPORIN) EYE DROPS ADMINISTERED ONCE DAILY ON THE QUALITY OF VISION IN DRY EYE DISEASE (DED) PATIENTS WITH SEVERE KERATITIS
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Summary
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EudraCT number |
2016-003497-40 |
Trial protocol |
FR |
Global end of trial date |
11 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Dec 2021
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First version publication date |
15 Dec 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NVG16E128
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03237936 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
SANTEN SAS
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Sponsor organisation address |
Genavenir IV, 1 rue Pierre Fontaine, EVRY, France,
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Public contact |
Elsa LLOBET-MERKLING, EURAXI PHARMA, e.llobetmerkling@euraxipharma.fr
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Scientific contact |
Elsa LLOBET-MERKLING, EURAXI PHARMA, e.llobetmerkling@euraxipharma.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Nov 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Jul 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jul 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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 following 3 months of treatment.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 17
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Worldwide total number of subjects |
17
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EEA total number of subjects |
17
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Study was conducted in 3 sites in France. | ||||||||||||
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Pre-assignment
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Screening details |
Overall, 20 patients were screened for the study and 19 patients were enrolled (1 screen failure patient). 2 patients withdrew before receiving any study medication and 17 patients were included in the FAS and safety populations. | ||||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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IKERVIS® 1 mg/mL CsA | ||||||||||||
Arm description |
Participants received IKERVIS® (1mg/mL CsA) eye drops administered once daily during the 3-month study period. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
IKERVIS®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Eye drops, emulsion
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Routes of administration |
Ocular use
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Dosage and administration details |
During the 3-month study treatment period, each patient was instructed to instil one drop of study medication (IKERVIS®, 1mg/mL CsA) into the lower conjunctival sac of each eye once daily at bedtime.
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IKERVIS® 1 mg/mL CsA
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Reporting group description |
Participants received IKERVIS® (1mg/mL CsA) eye drops administered once daily during the 3-month study period. | ||
Subject analysis set title |
Primary Endpoint
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
A total of 17 patients were included in the study.
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End point title |
Spearman's coefficient of 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. [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At Month 3
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This study is estimating the correlation of two measures VMR change and CFS change within the same group. No further statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Correlation between the change from baseline in variance of OSI measured with double pass aberrometer at Month 3 and the change from baseline in the CFS at Month 3. [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At Month 3
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This study is estimating the correlation of two measures OSI variance change and CFS change within the same group. No further statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From the time the patient gave informed consent until the final trial visit.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
Overall study
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 May 2017 |
Modification of an inclusion criteria, allowing to include patients rated 3 for the corneal fluorescein staining (CFS) test; specifying that certain exclusion criteria only applies to the eligible eye to be used for the statistical analysis, adding an assessment (non-corrected visual acuity). |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
