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
Conditions
Interventions
Trade Name: IKERVIS®
Pharmaceutical Form: Eye drops
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg/ml mi
Sponsors
SANTEN SAS
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. ; 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. ;Timepoint(s) of evaluation of this end point: At month 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At month 3.; 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. | — |
Countries
France
Contacts
Public ContactElsa LLOBET-MERKLING
EURAXI PHARMA
Outcome results
None listed