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Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Nitroglycerin
Isosorbide-Dinitrate
Sodium-nitroprusside
Physiologic saline solution (control substance)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glaucoma focused on measuring Nitrovasodilators, ONH blood flow, Choroidal blood flow, Nitroglycerin, Isosorbide Dinitrate, Sodium nitroprusside, Laser-Doppler Flowmetry, Regional Blood Flow

Eligibility Criteria

19 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men aged between 19 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile (Must et al. 1991)
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 3 Dpt.

Exclusion Criteria:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
  • History of migraine
  • Blood donation during the previous 3 weeks

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Nitroglycerin: (Perlinganit, Nycomet Heilmittelwerke, Vienna, Austria): 0, 0.25, 0.5, 1, 1.5 and 2 µg/kg/min, each infusion step for 20 minutes

Isosorbide-Dinitrate: (Isoket 0,1 %, Gebro Broschek, Fieberbrunn, Austria): 0, 0.5, 1, 2, 4 and 6 µg/kg/min , each infusion step for 20 minutes

Sodium-Nitroprusside: (Nipruss, Sanol-Schwarz, Monheim, Germany): 0, 0.25, 0.5, 1, 2 and 4 µg/kg/min, each infusion step for 20 minutes

Physiologic saline solution

Outcomes

Primary Outcome Measures

Optic disc blood flow (laser Doppler flowmetry)

Secondary Outcome Measures

Intraocular pressure
Choroidal blood flow (laser Doppler flowmetry)
Fundus pulsation amplitude in the macula (laser interferometry)
Fundus pulsation amplitude in the optic disc (laser interferometry)
Blood pressure, pulse rate

Full Information

First Posted
December 17, 2008
Last Updated
December 17, 2008
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00810381
Brief Title
Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects
Official Title
Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
June 1999 (Actual)
Study Completion Date
June 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Glaucoma, one of the most common causes of blindness, is associated with increased intraocular pressure (IOP) and optic nerve head ischemia. Nitrovasodilators are discussed in the treatment of glaucoma. Nitrates relax smooth muscle cells in the vasculature by liberating the vasodilator nitric oxide. The IOP lowering potential and the vasodilator action in retinal and choroidal vessels of nitrates is still a matter of controversy. Previous studies on the ocular hemodynamic effects of nitrates showed partially contradicting results. In addition the IOP lowering effect of nitrates is still unclear. However, recent studies show that long acting nitrates may preserve optic nerve deterioration and visual field loss. Therefore, the role of nitrovasodilators in control of ocular blood flow and intraocular pressure has to be elucidated. For this purpose the investigators plan to test the hypothesis that nitrovasodilators improve ocular blood supply to the optic nerve head at doses which do not affect systemic hemodynamics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Nitrovasodilators, ONH blood flow, Choroidal blood flow, Nitroglycerin, Isosorbide Dinitrate, Sodium nitroprusside, Laser-Doppler Flowmetry, Regional Blood Flow

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Nitroglycerin: (Perlinganit, Nycomet Heilmittelwerke, Vienna, Austria): 0, 0.25, 0.5, 1, 1.5 and 2 µg/kg/min, each infusion step for 20 minutes
Arm Title
2
Arm Type
Active Comparator
Arm Description
Isosorbide-Dinitrate: (Isoket 0,1 %, Gebro Broschek, Fieberbrunn, Austria): 0, 0.5, 1, 2, 4 and 6 µg/kg/min , each infusion step for 20 minutes
Arm Title
3
Arm Type
Active Comparator
Arm Description
Sodium-Nitroprusside: (Nipruss, Sanol-Schwarz, Monheim, Germany): 0, 0.25, 0.5, 1, 2 and 4 µg/kg/min, each infusion step for 20 minutes
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Physiologic saline solution
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
intravenous infusion; 0, 0.125, 0.25, 0.5, 1 and 2 µg/kg/min; 20 minutes per infusion step
Intervention Type
Drug
Intervention Name(s)
Isosorbide-Dinitrate
Intervention Description
intravenous infusion; 0, 0.5, 1, 2, 4, and 6 µg/kg/min; 20 minutes per infusion step
Intervention Type
Drug
Intervention Name(s)
Sodium-nitroprusside
Intervention Description
intravenous infusion; 0, 0.25, 0.5, 1, 2, and 4 µg/kg/min; 20 minutes per infusion step
Intervention Type
Drug
Intervention Name(s)
Physiologic saline solution (control substance)
Intervention Description
intravenous infusion, infusion period 120 minutes
Primary Outcome Measure Information:
Title
Optic disc blood flow (laser Doppler flowmetry)
Time Frame
in total 24x on 4 study days
Secondary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
in total 8x in 4 study days
Title
Choroidal blood flow (laser Doppler flowmetry)
Time Frame
in total 24x on 4 study days
Title
Fundus pulsation amplitude in the macula (laser interferometry)
Time Frame
in total 24x on 4 study days
Title
Fundus pulsation amplitude in the optic disc (laser interferometry)
Time Frame
in total 24x on 4 study days
Title
Blood pressure, pulse rate
Time Frame
on 4 study days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men aged between 19 and 35 years, nonsmokers Body mass index between 15th and 85th percentile (Must et al. 1991) Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, ametropia < 3 Dpt. Exclusion Criteria: Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug Symptoms of a clinically relevant illness in the 3 weeks before the first study day History of hypersensitivity to the trial drug or to drugs with a similar chemical structure History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs History of migraine Blood donation during the previous 3 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Georg Eichler, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects

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