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The Effects of an Antioxidant Formulation on Ocular Blood Flow

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ClinicalTrials.gov Identifier: NCT01930487
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
ScienceBased Health

Tracking Information
First Submitted Date  ICMJE August 9, 2013
First Posted Date  ICMJE August 29, 2013
Results First Submitted Date  ICMJE May 31, 2016
Results First Posted Date  ICMJE December 5, 2016
Last Update Posted Date December 5, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2013)
  • retinal capillary blood flow [ Time Frame: 30 days ]
    retinal capillary blood flow in arbitrary units.
  • Retrobulbar blood flow velocities and vascular resistance [ Time Frame: 30 days ]
    Central retinal artery, ophthalmic artery, and temporal and nasal short posterior artery: peak systolic and end diastolic blood flow velocities (cm/s) and vascular resistance (ratio).
Change History Complete list of historical versions of study NCT01930487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • Change in Ocular Perfusion Pressure [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)
  • Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
  • Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
  • Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
  • Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
  • Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
  • Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
  • Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
  • Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ]
    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
  • Change in Ocular Perfusion Pressure - DM [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes
  • Change in Ocular Perfusion Pressure - No DM [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes
  • Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM [ 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) in patients with type 2 diabetes
  • Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM [ 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) in patients without type 2 diabetes
  • Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM [ 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) in patients with type 2 diabetes
  • Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM [ 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) in patients without type 2 diabetes
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2013)
  • Ocular perfusion pressure [ Time Frame: 30 days ]
    2/3 Mean arterial pressure - intraocular pressure
  • Ocular pulse amplitude [ Time Frame: 30 days ]
    an measure used to estimate choroid blood flow in bulk
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of an Antioxidant Formulation on Ocular Blood Flow
Official Title  ICMJE The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow
Brief 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, increase ocular perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain these effects over the course of the treatment period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Primary Open Angle Glaucoma
Intervention  ICMJE
  • Dietary Supplement: dietary supplement with antioxidants
    Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
    Other Name: Optic Nerve Formula
  • Dietary Supplement: Placebo
    Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
Study Arms  ICMJE
  • Experimental: supplement w/ antioxidants then placebo
    dietary supplement with antioxidants, followed by placebo supplement
    Interventions:
    • Dietary Supplement: dietary supplement with antioxidants
    • Dietary Supplement: Placebo
  • Experimental: placebo then supplement w/ antioxidants
    placebo supplement, followed by dietary supplement with antioxidants
    Interventions:
    • Dietary Supplement: dietary supplement with antioxidants
    • Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2016)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2013)
30
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01930487
Other Study ID Numbers  ICMJE 007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ScienceBased Health
Study Sponsor  ICMJE ScienceBased Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alon Harris, PhD Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
PRS Account ScienceBased Health
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP