GlaucomaNCT00810381
Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects
A study testing Nitroglycerin, Isosorbide-Dinitrate and Sodium-nitroprusside in people with Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Nitroglycerin, Isosorbide-Dinitrate and Sodium-nitroprusside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- Jan 1999to Jun 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
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.
- Conditions
- Glaucoma
- Being tested
- Nitroglycerin, Isosorbide-Dinitrate, Sodium-nitroprusside, Physiologic saline solution (control substance)
- Keywords
- Nitrovasodilators, ONH blood flow, Choroidal blood flow, Nitroglycerin, Isosorbide Dinitrate, Sodium nitroprusside, Laser-Doppler Flowmetry, Regional Blood Flow
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
intravenous infusion; 0, 0.125, 0.25, 0.5, 1 and 2 µg/kg/min; 20 minutes per infusion step
Isosorbide-DinitrateDrug
intravenous infusion; 0, 0.5, 1, 2, 4, and 6 µg/kg/min; 20 minutes per infusion step
Sodium-nitroprussideDrug
intravenous infusion; 0, 0.25, 0.5, 1, 2, and 4 µg/kg/min; 20 minutes per infusion step
Physiologic saline solution (control substance)Drug
intravenous infusion, infusion period 120 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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 Receives: Drug: Nitroglycerin |
| 2 | Active comparator | 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 Receives: Drug: Isosorbide-Dinitrate |
| 3 | Active comparator | 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 Receives: Drug: Sodium-nitroprusside |
| 4 | Placebo comparator | Physiologic saline solution Receives: Drug: Physiologic saline solution (control substance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic disc blood flow (laser Doppler flowmetry)
Measured: in total 24x on 4 study days
Secondary outcomes (5)
Intraocular pressure
Measured: in total 8x in 4 study days
Choroidal blood flow (laser Doppler flowmetry)
Measured: in total 24x on 4 study days
Fundus pulsation amplitude in the macula (laser interferometry)
Measured: in total 24x on 4 study days
Fundus pulsation amplitude in the optic disc (laser interferometry)
Measured: in total 24x on 4 study days
Blood pressure, pulse rate
Measured: on 4 study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 1999
- Primary completionJun 1999
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Georg Eichler, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810381
- Sponsor's protocol ID
- OPHT-211097
- Status last verified
- Dec 2008
- First submitted
- 17 Dec 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00810381
- Acronym / sponsor ID
- OPHT-211097
- Conditions
- Glaucoma
- Keywords
- Nitrovasodilators, ONH blood flow, Choroidal blood flow, Nitroglycerin, Isosorbide Dinitrate, Sodium nitroprusside, Laser-Doppler Flowmetry, Regional Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Jun 1999 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: NitroglycerinNitroglycerin: (Perlinganit, Nycomet Heilmittelwerke, Vienna, Austria): 0, 0.25, 0.5, 1, 1.5 and 2 µg/kg/min, each infusion step for 20 minutes |
| 2 | Active comparator | Drug: Isosorbide-DinitrateIsosorbide-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 |
| 3 | Active comparator | Drug: Sodium-nitroprussideSodium-Nitroprusside: (Nipruss, Sanol-Schwarz, Monheim, Germany): 0, 0.25, 0.5, 1, 2 and 4 µg/kg/min, each infusion step for 20 minutes |
| 4 | Placebo comparator | Drug: Physiologic saline solution (control substance)Physiologic saline solution |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerinintravenous infusion; 0, 0.125, 0.25, 0.5, 1 and 2 µg/kg/min; 20 minutes per infusion step | Drug | 1 |
| Isosorbide-Dinitrateintravenous infusion; 0, 0.5, 1, 2, 4, and 6 µg/kg/min; 20 minutes per infusion step | Drug | 2 |
| Sodium-nitroprussideintravenous infusion; 0, 0.25, 0.5, 1, 2, and 4 µg/kg/min; 20 minutes per infusion step | Drug | 3 |
| Physiologic saline solution (control substance)intravenous infusion, infusion period 120 minutes | Drug | 4 |
Primary outcome
Optic disc blood flow (laser Doppler flowmetry)
Time frame: in total 24x on 4 study days
5 secondary outcomes
Intraocular pressure
Time frame: in total 8x in 4 study days
Choroidal blood flow (laser Doppler flowmetry)
Time frame: in total 24x on 4 study days
Fundus pulsation amplitude in the macula (laser interferometry)
Time frame: in total 24x on 4 study days
Fundus pulsation amplitude in the optic disc (laser interferometry)
Time frame: in total 24x on 4 study days
Blood pressure, pulse rate
Time frame: on 4 study days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Georg Eichler, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerin, Isosorbide-Dinitrate and Sodium-nitroprusside in people with Glaucoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic disc blood flow (laser Doppler flowmetry) (time frame: in total 24x on 4 study days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008.