E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dry Eye |
Zespół Suchego Oka |
|
E.1.1.1 | Medical condition in easily understood language |
Dry eye |
Zespół Suchego Oka |
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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 | LLT |
E.1.2 | Classification code | 10013778 |
E.1.2 | Term | Dry eyes |
E.1.2 | System Organ Class | 100000004853 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013777 |
E.1.2 | Term | Dry eye syndrome |
E.1.2 | System Organ Class | 100000004853 |
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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 evaluate the efficacy of T1580 versus vehicle in Dry Eye Disease (DED). |
Głównym celem tego badania jest ocena skuteczności preparatu T1580 w porównaniu do nieaktywnego nośnika leku w Zespole Suchego Oka (ZSO). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the safety of T1580. |
Drugorzędowym celem jest ocena bezpieczeństwa preparatu T1580. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Ancillary study : sampling of conjunctiva cells for the measurement of HLA-DR and blood sample for pharmacokinetics.
These samplings will be performed in a subset of patients in selected sites in order to obtain some interpretable blood samples and some conjunctival cytology impression samples.
|
Badanie pomocnicze: pobranie komórek spojówki do oceny HLA-DR i próbki krwi do badań farmakokinetycznych.
Te badania zostaną wykonane w podgrupie pacjentów w wybranych ośrodkach aby uzyskać poddawane ocenie próbki krwi i próbki spojówkowej cytologii impresyjnej. |
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E.3 | Principal inclusion criteria |
Informed consent signed and dated Menopausal woman Patient with BILATERAL persistent DED
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Podpisana i datowana Świadoma Zgoda Kobiety po menopauzie Pacjentki z obustronnym utrzymującym się Zespołem Suchego Oka (ZSO) |
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E.4 | Principal exclusion criteria |
Presence of an active condition : a. Ocular rosacea, uveitis, b. Abnormal eye lid anatomy, blinking, or naso-lachrymal drainage system, c. Ocular hypertension or glaucoma requiring an ophthalmic medicinal product, d. Infectious conjunctivitis, severe blepharitis, and/or progressive pterygium. Major corneal hypoaesthesia value ≤ 20 mm as measured with a Cochet-Bonnet aesthesiometer. Far best corrected visual acuity (BCVA) worse than or equal to + 0.7 LogMar. Any history of, or active, relevant ocular disorder condition other than those listed above which is likely to interfere with the study results as judged by the investigator at Screening or Baseline visits. Any ophthalmic disease likely to change the assessment of fluctuating blurred vision linked to dry eye disease or may result in a visual acuity deterioration in the following year.
Other exclusion criteria are defined in the protocol (Exclusion criteria regarding ocular history, Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions). |
Występujące obecnie: a. Trądzik różowaty oka, zapalenie błony naczyniowej oka, b. Nieprawidłowa anatomia powieki oka, mruganie czy też nieprawidłowa anatomia nosowo-łzowego układu drenażowego, c. Nadciśnienie oczu lub jaskra wymagająca podawania produktów medycznych, d. Infekcyjne zapalenie spojówek, ostre zapalenie powiek i/lub postępujący skrzydlik Znaczna niedoczulica rogówki ≤ 20 mm mierzona estezjometrem Cochet-Bonnet podczas wizyty przesiewowej. Najlepsza skorygowana ostrość widzenia gorsza lub równa + 0,7 LogMar (≥ + 0,7 LogMar; np. ≤ 0,2 w wartościach dziesiętnych lub ≤ 20/100 odpowiednik Snellena lub ≤ 50 ETDRS) podczas wizyty przesiewowej lub kwalifikacyjnej. Wszelkie choroby oczu, które mogą wpłynąć na ocenę zmieniającego się nieostrego widzenia powiązane z Zespołem Suchego Oka lub które mogą powodować pogorszenie się ostrości widzenia w ciągu kolejnego roku.
Inne kryteria wykluczenia są zdefiniowane w protokole (okulistyczne kryteria wykluczenia z badania, systemowe/nie okulistyczne kryteria, specyficzne kryterium odnoszące się do kobiet w wieku rozrodczym, kryteria wykluczenia odnoszące się do stanu ogólnego pacjentki.) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The change from Baseline in Corneal Fluorescein Staining (CFS) |
Zmiana od wizyty kwalifikacyjnej w barwieniu rogówki fluoresceiną (CFS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessed at Month 6 |
Ocena po 6 miesiącach |
|
E.5.2 | Secondary end point(s) |
Key Secondary efficacy Endpoints -CFS response to treatment -Combined CFS and OSDI response to treatment
|
Kluczowe drugorzędowe punktu końcowe oceny skuteczności - Barwienie rogówki fluoresceiną (CFS) - Łączona ocena odpowiedzi na leczenie w barwieniu rogówki fluoresceiną (CFS) na podstawie kwestionariusza OSDI (Współczynnik Chorób Powierzchni Oka) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessed at Month 6
|
Ocena po 6 miesiącach |
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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 | No |
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 |
Po pierwszych 6-ciu m-cach okresu podwójnie ślepej próby nastąpi otwarty okres 6-ciu m-cy leczeni |
The first 6-month period will be double-masked followed by an open-label 6-month treatment period |
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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 | 66 |
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 |
Armenia |
Austria |
Belgium |
Bosnia and Herzegovina |
Bulgaria |
Croatia |
Czech Republic |
Estonia |
Georgia |
Greece |
Hungary |
Italy |
Latvia |
Lithuania |
Poland |
Romania |
Russian Federation |
Serbia |
Ukraine |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Last patient Last Visit |
Ostatnia wizyta ostatniego pacjenta |
|
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 | 7 |
E.8.9.1 | In the Member State concerned days | |
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 |