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 | 14.1 |
E.1.2 | Level | LLT |
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 | 14.1 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 | 14.1 |
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.1.3 | 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 the extension study is to assess the duration of the improvement (time to relapse) following NOVA22007 treatment discontinuation once the patient is markedly improved (CFS ≤ 2) with respect to the baseline of the main study |
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E.2.2 | Secondary objectives of the trial |
- To assess the duration of the improvement following NOVA22007 treatment discontinuation in improved patients in comparison to the baseline of the main study (at least 1 grade on the modified Oxford scale, i.e. from CFS ≥ 4 to CFS ≤ 3). - To assess the duration of improvement following NOVA22007 treatment discontinuation in all patients who participated to the extension study. - To determine whether prognostic factors explain the duration of the improvement. - To estimate the time spent on NOVA22007 treatment per year in all patients, in those who reached CFS ≤ 2 at least once during the extension study as well as those who reached CFS ≤ 3. - To estimate the time spent on each CFS score per year in all patients and in those who reached CFS ≤ 2 and those who reached CFS ≤ 3. - To assess the time to onset of action (CFS ≤ 2) once NOVA22007 treatment is resumed because of worsening (CFS ≥ 4). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient completed the main study (NVG10E117). 2. Patient was treated with NOVA22007 during the last 6 months. 3. Patient must provide written informed consent for the extension study. 4. Patient must be willing and able to undergo and return for scheduled study-related examinations |
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E.4 | Principal exclusion criteria |
Patients will not be eligible for inclusion in the extension study if one of the following criteria is met: 1. Drop out from the main study (NVG10E117). 2. Completion of last visit Month 12 of the main study (NVG10E117) more than 2 weeks ago. 3. Resistance to treatment. A patient is considered treatment resistant at Month 12 if at Month 9 and 12 visits CFS score was at grade 4 or 5. (The patient is not treatment resistant and consequently eligible if at Month 12 visit the grade was 4 or more but at Month 9 visit the grade was 3 or less). 4. Active herpes Keratitis or history of ocular herpes. 5. Active ocular infection (viral, bacterial, fungal, protozoal). 6. Presence or history of any systemic or ocular disorder, condition ordisease 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. 7. 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 vasectomized partner) 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. 8. Current participation in another clinical trial than the main study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to relapse following NOVA22007 treatment discontinuation in markedly improved patients |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
timepoints evaluations will be patient dependant |
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E.5.2 | Secondary end point(s) |
1. Time to relapse following NOVA22007 treatment discontinuation in improved patients. 2. Duration of improvement following treatment discontinuation if any in all included patients. 3. Time spent on NOVA22007 treatment per year; 4. Time spent on each CFS score per year 5. Time to onset of action following NOVA22007 treatment resumption |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
timepoints evaluation will be patient dependant |
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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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |