E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Effect of one eye drop of IKERVIS® on the quality of the vision in Dry Eye Disease patients with severe keratitis. |
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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 | 19.1 |
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 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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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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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) |
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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |