Elevated eyepressure MedDRA version: 16.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 16.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Harju Mika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Open angle glaucoma and ocular hypertension patients with intraocular pressure 22-34 mmHg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in eyepressure in two different groups: total dose 1 mmol/kg and two doses of 0.5 mmol/kg between 10 minutes;Secondary Objective: Blood pressure, pulse;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;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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. | — |
Countries
Finland
Outcome results
None listed