E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intraocular pressure increase caused by glucocorticoid use in genetically predisposed patients |
Silmänpaineen nousu siihen herkillä potilailla glukokortikoidihoidon aiheuttamana |
|
E.1.1.1 | Medical condition in easily understood language |
Intraocular pressure increase caused by glucocorticoid use in genetically predisposed patients |
Silmänpaineen nousu siihen herkillä potilailla glukokortikoidihoin aiheuttamana |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
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 |
Prevention of intraocular pressure raise (group 1+3), decrease in intraocular pressure (group 2) |
Silmänpaineen nousun esto (ryhmät 1+3, silmänpaineen lasku (ryhmä 2) |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with glucocorticoid caused raise in intraocular pressure encountered in clinical work at Helsinki University Hospital Uveitis dpt |
Potilaat, joilla kortisoni aiheuttaa silmänpaineen nousua (potilaat rekrytoidaan HYKS Silmäklinikan uveiittipoliklinikan potilaista) |
|
E.4 | Principal exclusion criteria |
Age (<18 or >65 years), gravid and nursing mothers |
Ikä (ei lapsia eikä vanhuksia), raskaana olevat sekä imettävät |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Group 1+3: Patients receive similar glucocorticoid treatment in phase 2 as they do in phase 1. In phase one duration and magnitude of treatment is determined individually based on tendency for IOP rise Group 2: prevention of glaucoma operation and management of uveitis with other, more slow-acting medication |
Ryhmä 1+3: Vaiheessa 1 potilaat saavat yksilöllisen annostuksen kortisonisilmätippoja, annostus perustuu siihen kuinka herkkiä he paineennousulle ovat. Annostelu loppuu kun paine ylittää 30 ja 2-vaiheessa potilaat saavat saman annostuksen, Ryhmässä 2 tavoitteena on estää silmänpaineoperaatio. Lääkitys loppuu kun muilla tulehduslääkkeillä (hitaammin vaikuttavat) saadaan tulehdus niin rauhoittumaan että kortisoniannosta (ja tämän myötä paineennousua) voidaan vähentää |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
In phase 2 patients receive glucocorticoid medication with same duration as in phase 1 (individually determined) |
Vaiheessa 2 potilaat saavat samankestoisen lääkityksen kuin vaiheessa 1. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
No other end points |
Ei muita päätepisteitä |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.5 | 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
|
When phase 2 medication is finished, patients are controlled until the intraocular pressure has normalized. After that the normal treatment at Helsinki university Hospital uveitis dpt continues |
Kun kortisoni + PBA (vaihe 2) loppuvat niin potilaita seurataan tutkimuksen puolesta kunnes paine on normaalistunut mikäli se on noussut. Tämän jälkeen potilaiden hoito jatkuu normaaliin tapaan HYKS Silmäklinikan uveiittipoliklinikalla |
|
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 | |