Effect of IKERVIS® eye drops administrated once daily on the quality of vision in dry eye disease patients with severe keratitis.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2016-003497-40-FR
• Date of registration: 10/01/2017
• Prospective Registration: No
• Primary sponsor: SANTEN SAS
• Public title: Effect of IKERVIS® eye drops administrated once daily on the quality of vision in dry eye disease patients with severe keratitis.
• Scientific title: 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
• Date of first enrolment: 28/12/2016
• Target sample size: 33
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003497-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

France

Contacts

• Name: Elsa LLOBET-MERKLING
• Affiliation: EURAXI PHARMA

• Name: Elsa LLOBET-MERKLING
• Affiliation: EURAXI PHARMA

Key inclusion & exclusion criteria

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 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Effect of one eye drop of IKERVIS®on adult male or female (aged 18 years or above) Dry Eye Disease patients with severe keratitis despite the use of tear substitutes.
MedDRA version: 19.1 Level: PT Classification code 10023332 Term: Keratitis System Organ Class: 10015919 - Eye disorders

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Trade Name: IKERVIS®
Pharmaceutical Form: Eye drops
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Secondary Objective: • To assess the signs and symptoms of keratitis and DED, and their changes overtime.
• To evaluate the ocular tolerability and overall ocular safety of IKERVIS® administered once daily in DED patients with severe keratitis at Month 3.

Timepoint(s) of evaluation of this end point: At month 3.

Primary end point(s): Efficacy endpoints
Correlation between the change from baseline in quality of vision and the change from baseline in the CFS at Month 3.

Main Objective: 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.

Secondary Outcome(s)

Secondary end point(s): Main secondary endpoint(s) with time points(s) of assessment
Efficacy endpoints
• CFS score assessed with the Modified Oxford Scale and change from baseline at Months 1, 2 and 3.
• Quality of vision parameters and their changes from baseline at Months 1, 2 and 3.
• Tear Break Up Time (TBUT) and change from baseline at Months 1, 2 and 3.
• Investigator Global Evaluation of Efficacy at Month 3.
• Patient Global Evaluation of Efficacy at Month 3.
• Artificial Tear use and change from baseline at Months 1, 2 and 3, and changes from baseline

Safety evaluations:
• Slit lamp examination and change from baseline at Months 1, 2 and 3.
• Incidence and severity of ocular and systemic adverse events over the study period.

Timepoint(s) of evaluation of this end point: At month 3.

Secondary ID(s)

NVG16E128

Source(s) of Monetary Support

SANTEN SAS

Ethics review

Status: Approved
Approval date:
Contact: