E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
DRY EYE DISEASE WITH SEVERE KERATITIS |
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E.1.1.1 | Medical condition in easily understood language |
Dry Eye Disease with a severly inflamed cornea |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023332 |
E.1.2 | Term | Keratitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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)
To assess the ocular surface complications over the three-year study period. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy parameters (signs and symptoms), the ocular surface complications, and the quality of life over treatment Periods 1 and 2.
To evaluate the safety and tolerability of IKERVIS® (1mg/mL ciclosporin) eye drops treatment over the three-year study period.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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.
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E.4 | Principal exclusion criteria |
- 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- The correlation between mean change from baseline in CFS score and symptoms
- Incident rate and time to onset of ocular surface complications |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Efficacy:
• CFS score and change from baseline at each visit
• Conjunctival fluorescein staining score and change from baseline at each visit
• symptoms score and change from baseline at each visit
• TBUT and change from baseline at each visit
• Schirmer test and change from baseline
• Use of Artificial Tears
• Incidence and severity of ocular and systemic adverse events (AEs) over the three-year study period.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Period 1- Baseline to month 12
Period 2 - Month 12 to month 36 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Period 1 -Open; Period 2 - double-blind |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Czech Republic |
France |
Italy |
Poland |
Russian Federation |
Spain |
Turkey |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |