A three-year study to explore the long-term evolution of sign and symptoms of severe Dry Eye Disease in patients receiving IKERVIS® (1mg/ml ciclosporin) eye drops.
- Conditions
- Therapeutic area: Diseases [C] - Eye Diseases [C11]DRY EYE DISEASE WITH SEVERE KERATITISMedDRA version: 20.0Level: PTClassification code 10023332Term: KeratitisSystem Organ Class: 10015919 - Eye disorders
- Registration Number
- EUCTR2017-002660-41-PL
- Lead Sponsor
- SANTEN SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 350
- In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
- The patient has signed and dated 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.
- At least 4 weeks of use of tear substitutes prior to the Baseline Visit.
- DED patients with severe keratitis
- Patient must be willing and able to undergo and return for scheduled study-related examinations.
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 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175
- Best corrected distance visual acuity (BCDVA) score = 20/200 Snellen in each eye.
- Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of study results or judged by the investigator to be incompatible with the study (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease, current systemic infections, ocular infection…).
- Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc...).
- History of ophthalmic malignancy.
- History of malignancy (other than ophthalmic) in the last 5 years
- Any change in systemic immunosuppressant drugs within 30 days before the Baseline Visit or anticipated change during the course of the study.
- Pregnancy or lactation at the Baseline Visit.
- Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomised partner) from the Baseline Visit throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
- Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline Visit.
- Participation in another clinical study at the same time as the present study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term efficacy of a continuous treatment of IKERVIS® (1mg/mL ciclosporin) eye drops in adult dry eye disease (DED) patients with severe keratitis on corneal sign and DED symptoms, and to estimate the lag time (if any) to improvement in symptoms (if any)<br><br>To assess the ocular surface complications over the three-year study period.;Secondary Objective: To evaluate the efficacy parameters (signs and symptoms), the ocular surface complications, and the quality of life over treatment Periods 1 and 2.<br><br>To evaluate the safety and tolerability of IKERVIS® (1mg/mL ciclosporin) eye drops treatment over the three-year study period.<br>;Primary end point(s): - The correlation between mean change from baseline in CFS score and symptoms <br><br>- Incident rate and time to onset of ocular surface complications;Timepoint(s) of evaluation of this end point: Throughout the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy:<br>• CFS score and change from baseline at each visit <br>• Conjunctival fluorescein staining score and change from baseline at each visit<br>• symptoms score and change from baseline at each visit <br>• TBUT and change from baseline at each visit <br>• Schirmer test and change from baseline<br>• Use of Artificial Tears<br>• Incidence and severity of ocular and systemic adverse events (AEs) over the three-year study period.<br>;Timepoint(s) of evaluation of this end point: Period 1- Baseline to month 12<br><br>Period 2 - Month 12 to month 36