E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elevated eyepressure |
Kohonnut silmänpaine |
|
E.1.1.1 | Medical condition in easily understood language |
Elevated eyepressure |
Kohonnut silmänpaine |
|
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 | 16.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10018307 |
E.1.2 | Term | Glaucoma and ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
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 |
Change in eyepressure in two different groups: total dose 1 mmol/kg and two doses of 0.5 mmol/kg between 10 minutes |
Silmänpaineen muutos kahdessa eri ryhmässä: kokonaisannos 1 mmol/kg ja kaksi toistettua annosta 0.5 mmol/kg 10 min välein |
|
E.2.2 | Secondary objectives of the trial |
Blood pressure, pulse |
Verenpaine, pulssi |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Open angle glaucoma and ocular hypertension patients with intraocular pressure 22-34 mmHg |
Avokulmaglaukoomapotilaat ja potilaat joilla on okulaarinen hypertensio, ja silmänpaine on välillä 22-24 mmHg |
|
E.4 | Principal exclusion criteria |
Ödemin medication, age under 25 years, age higher than 80 years, kidney failure, heart failure, dementia, other medical disorder that affects significantly patients condition |
Ödemin-lääkitys, ikä alle 25 vuotta, ikä päälle 80 vuotta, munuaisten tai sydämen vajaatoiminta, dementia, muu sairaus joka huomattavasti alentaa potilaan yleistilaa |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Eyepressure aften one 1 mmol/kg 23,4% NaCl or after two repeating doses of 0.5 mmol/kg 23,4% NaCl |
Silmänpaine 1 mmol/kg 23,4% NaCl-liuoksen kerta-annoksen jälkeen tai silmänpaine kahden toistetun 23,4% NaCl 0.5 mmol/kg annoksen jälkeen |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
20 minutes in 1.0 mmol/kg group and 30 minutes in 0.5 mmol/kg x2 group |
20 minuutin kohdalla 1.0 mmol/kg ryhmän potilailla ja 30 minuutin kohdalla 0.5 mmol/kgx2 ryhmässä |
|
E.5.2 | Secondary end point(s) |
Eyepressure aften one 1 mmol/kg 23,4% NaCl or after two repeating doses of 0.5 mmol/kg 23,4% NaCl |
Silmänpaine 1 mmol/kg 23,4% NaCl-liuoksen kerta-annoksen jälkeen tai silmänpaine kahden toistetun 23,4% NaCl 0.5 mmol/kg annoksen jälkeen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.0 mmol/kg group: 0, 3, 6, 13, 10, 13 and 16 minutes.
0.5 mmol/kg x2 group: 0, 3, 6, 10, 13, 16, 20, 23 and 26 minutes. |
1.0 mmol/kg ryhmä: 0, 3, 6, 13, 10, 13 and 16 minuuttia.
0.5 mmol/kg x2 ryhmä: 0, 3, 6, 10, 13, 16, 20, 23 and 26 minuuttia. |
|
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) | 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 | 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 | 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 we have examinated at least 13 patients in both groups, total 26 patients minimum |
Kun olemme tutkineet molemmissa ryhmissä vähintään 13 potilasta eli yhteensä vähintään 26 potilasta |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |