Strong saline - the effect of repeating doses

Conditions: Elevated eyepressure
MedDRA version: 16.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 16.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-001733-41-FI

Lead Sponsor: Harju Mika

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

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

Ödemin medication, age under 25 years, age higher than 80 years, kidney failure, heart failure, dementia, other medical disorder that affects significantly patients condition

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>0.5 mmol/kg x2 group: 0, 3, 6, 10, 13, 16, 20, 23 and 26 minutes.