E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013774 |
E.1.2 | Term | Dry eye |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013777 |
E.1.2 | Term | Dry eye syndrome |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023350 |
E.1.2 | Term | Keratoconjunctivitis sicca |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013778 |
E.1.2 | Term | Dry eyes |
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 |
The primary objective of this study is to demonstrate the superiority of CYCLOKAT® 1mg/ml (ciclosporin/cyclosporine) eye drops, emulsion over vehicle administered once daily in patients with severe DED after 6 months of treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the ocular tolerability and overall ocular safety of CYCLOKAT® administered once daily in patients with severe DED over 12 months. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, from 18 years of age. 2. Patients with persistent severe DED at the Screening and Baseline Visits 3. Patient must provide written informed consent. 4. Patient must be willing and able to undergo and return for scheduled study-related examinations. 5. The same eye (eligible eye) should fulfill all the above criteria.
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E.4 | Principal exclusion criteria |
1. Dry eye disease resulting from the destruction of conjunctival goblet cells or scarring. 2. Any relevant ocular anomaly other than DED interfering with the ocular surface including trauma, post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history, etc. 3. Abnormal lid anatomy, abnormalities of the nasolachrymal drainage system or blinking function in either eye. 4. Anticipated use of temporary punctal plugs during the study. Patients with punctal plugs placed prior to screening are eligible for enrolment, however, punctual plugs must remain in place during the study. 5. Active herpes keratitis or history of ocular herpes. 6. Within the 90 days before the Screening Visit history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal). 7. History of non-infectious ocular inflammation not associated with dry eye (e.g. uveitis, scleritis, peripheral ulcerative keratitis). 8. Any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study. Patients taking BAK-free IOP lowering medications are eligible for study enrolment. 9. Patients with severe blepharitis and/or Meibomian Gland Disease (MGD). Patients enrolled with mild to moderate blepharitis and/or MGD should be treated as appropriate during the study. 10. Patients with active rosacea and/or progressive pterygium. 11. History of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye. 12. Contact lenses wear during the study. 13. Any prior refractive surgery (i.e., LASIK, LASEK, PRK, etc). These procedures are not allowed during the course of the study. 14. Ocular laser/surgery other than refractive surgery (including palpebral and cataract surgery) within 90 days before the study. Elective ocular laser/surgery is not allowed during the course of the study. 15. Best corrected distance visual acuity (BCDVA) score ≥ +1.0 LogMAR (≤ 35 ETDRS letters, ≤ 20/200 Snellen or ≤ 0.1) in each eye.
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E.5 End points |
E.5.1 | Primary end point(s) |
- an improvement from baseline of corneal fluorescein staining score (CFS) assessed with the modified Oxford scale - an improvement in OSDI score
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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) |
- CFS score assessed with the modified Oxford scale. - OSDI score - VAS score - Schirmer Test score without anesthesia - Complete Corneal Clearing - Artificial Tear use - Investigator Global Evaluation of Efficacy
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints of evaluation of secondary endpoints will be at Month 1, 3, 6 |
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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 | 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 | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
6 month double masked period followed by a 6 months open period for all patients |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 |
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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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Last visit of the last subject (LVLS) |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |