Primary Open Angle GlaucomaNCT01930487
The Effects of an Antioxidant Formulation on Ocular Blood Flow
A study testing dietary supplement with antioxidants in people with Primary Open Angle Glaucoma, run by ScienceBased Health at 1 site in United States.
Trial summary
The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular blood flow in a randomized double-blind, crossover design. Based upon preliminary data, it is hypothesized that a dietary supplement containing a variety of ingredients with antioxidant properties will, compared to placebo… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- dietary supplement with antioxidants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 years or older.
- Confirmed diagnosis of open angle glaucoma by glaucoma specialist in the study eye, as evidenced from criteria representative of glaucomatous optic nerve damage such as specific optic disc or retinal nerve fiber layer structural abnormalities and/or visual field abnormalities.
- Best corrected visual acuity at 20/60 or better in study eye.
- Willingness to avoid caffeine and smoking for 12 hours before and during the study visits.
Who cannot join
- History of acute angle-closure or a narrow, occluding of anterior chamber angle by gonioscopy.
- History of chronic or recurrent inflammatory eye diseases or signs of intraocular trauma and/or unreliable applanation tonometry.
- Severe, unstable or uncontrolled cardiovascular, renal or pulmonary disease
- History of/or current renal or hepatic impairment.
- History of/or current bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiogenic shock.
- Recent surgery or surgery planned near study timeline
Show all 9Show fewer
- History of bleeding disorder
- Use of blood thinning medications
- Use of specified dietary supplements for three weeks prior to study entry and throughout study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow
The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular blood flow in a randomized double-blind, crossover design.
Based upon preliminary data, it is hypothesized that a dietary supplement containing a variety of ingredients with antioxidant properties will, compared to placebo, increase ocular perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain these effects over the course of the treatment period.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- dietary supplement with antioxidants, Placebo
- Keywords
- Primary open angle glaucoma, intraocular pressure, ocular perfusion pressure, retrobulbar blood flow, retinal capillary blood flow, choroidal blood flow
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement with antioxidantsDietary supplement
Also called Optic Nerve Formula
Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
PlaceboDietary supplement
Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
| Study group | Role | What they receive |
|---|---|---|
| supplement w/ antioxidants then placebo | Experimental | dietary supplement with antioxidants, followed by placebo supplement Receives: Dietary Supplement: dietary supplement with antioxidants; Dietary Supplement: Placebo |
| placebo then supplement w/ antioxidants | Experimental | placebo supplement, followed by dietary supplement with antioxidants Receives: Dietary Supplement: dietary supplement with antioxidants; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)
change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
Measured: baseline and 30 days
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)
change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
Measured: baseline and 30 days
Secondary outcomes (43)
Change in Ocular Perfusion Pressure
change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)
Measured: baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)
change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)
change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Measured: baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM
change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM
change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM
change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM
change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Ocular Perfusion Pressure - DM
change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Ocular Perfusion Pressure - No DM
change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM
change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM
change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes
Measured: baseline and 30 days
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM
change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes
Measured: baseline and 30 days
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM
change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes
Measured: baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- ScienceBased Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alon Harris, PhD, Principal investigator, Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930487
- Sponsor's protocol ID
- 007
- Status last verified
- Jan 2016
- First submitted
- 9 Aug 2013
- Last updated
- 5 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow
- ClinicalTrials.gov ID
- NCT01930487
- Acronym / sponsor ID
- 007
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Primary open angle glaucoma, intraocular pressure, ocular perfusion pressure, retrobulbar blood flow, retinal capillary blood flow, choroidal blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- ScienceBased HealthIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular blood flow in a randomized double-blind, crossover design.
Based upon preliminary data, it is hypothesized that a dietary supplement containing a variety of ingredients with antioxidant properties will, compared to placebo, increase ocular perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain these effects over the course of the treatment period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supplement w/ antioxidants then placebo | Experimental | Dietary Supplement: dietary supplement with antioxidants, Dietary Supplement: Placebodietary supplement with antioxidants, followed by placebo supplement |
| placebo then supplement w/ antioxidants | Experimental | Dietary Supplement: dietary supplement with antioxidants, Dietary Supplement: Placeboplacebo supplement, followed by dietary supplement with antioxidants |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30 years or older.
- Confirmed diagnosis of open angle glaucoma by glaucoma specialist in the study eye, as evidenced from criteria representative of glaucomatous optic nerve damage such as specific optic disc or retinal nerve fiber layer structural abnormalities and/or visual field abnormalities.
- Best corrected visual acuity at 20/60 or better in study eye.
- Willingness to avoid caffeine and smoking for 12 hours before and during the study visits.
Key exclusion criteria (9 listed)
- History of acute angle-closure or a narrow, occluding of anterior chamber angle by gonioscopy.
- History of chronic or recurrent inflammatory eye diseases or signs of intraocular trauma and/or unreliable applanation tonometry.
- Severe, unstable or uncontrolled cardiovascular, renal or pulmonary disease
- History of/or current renal or hepatic impairment.
- History of/or current bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiogenic shock.
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 |
|---|---|---|
| dietary supplement with antioxidantsAlso: Optic Nerve FormulaFormulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids | Dietary supplement | placebo then supplement w/ antioxidants, supplement w/ antioxidants then placebo |
| PlaceboPlacebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants | Dietary supplement | placebo then supplement w/ antioxidants, supplement w/ antioxidants then placebo |
Primary outcome
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)
Time frame: baseline and 30 days
change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)
Time frame: baseline and 30 days
change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
43 secondary outcomes
Change in Ocular Perfusion Pressure
Time frame: baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
Time frame: baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)
Time frame: baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)
Time frame: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
Time frame: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
Time frame: baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Time frame: baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Time frame: baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM
Time frame: baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Time frame: baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM
Time frame: baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Time frame: baseline and 30 days
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
Time frame: baseline and 30 days
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Time frame: baseline and 30 days
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
Time frame: baseline and 30 days
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Time frame: baseline and 30 days
Change in Ocular Perfusion Pressure - DM
Time frame: baseline and 30 days
Change in Ocular Perfusion Pressure - No DM
Time frame: baseline and 30 days
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM
Time frame: baseline and 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alon Harris, PhD principal investigator
Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement with antioxidants in people with Primary Open Angle Glaucoma, run by ScienceBased Health at 1 site in United States.
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 4 inclusion and 9 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 5 Dec 2016. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) (time frame: baseline and 30 days). The study lists 2 primary outcomes in all. 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 5 Dec 2016; AzTrials last refreshed its copy on 7 Nov 2026.