The Effects of an Antioxidant Formulation on Ocular Blood Flow

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by ScienceBased Health
Sponsor:
Information provided by (Responsible Party):
ScienceBased Health
ClinicalTrials.gov Identifier:
NCT01930487
First received: August 9, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Primary Open Angle Glaucoma
Dietary Supplement: dietary supplement with antioxidants
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow

Resource links provided by NLM:


Further study details as provided by ScienceBased Health:

Primary Outcome Measures:
  • retinal capillary blood flow [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    retinal capillary blood flow in arbitrary units.

  • Retrobulbar blood flow velocities and vascular resistance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Ocular perfusion pressure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    2/3 Mean arterial pressure - intraocular pressure

  • Ocular pulse amplitude [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    an measure used to estimate choroid blood flow in bulk


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dietary supplement with antioxidants
Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
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

Experimental: placebo
Placebo identical in appearance to active
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


  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930487

Contacts
Contact: Brent A. Siesky, PhD 317-278-0177 bsiesky@indiana.edu
Contact: Alon Harris, PhD 317-278-0177 alharris@indiana.edu

Locations
United States, Indiana
Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Brent A Siesky, PhD    317-278-0177    bsiesky@indiana.edu   
Sponsors and Collaborators
ScienceBased Health
Investigators
Principal Investigator: Alon Harris, PhD Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
  More Information

No publications provided

Responsible Party: ScienceBased Health
ClinicalTrials.gov Identifier: NCT01930487     History of Changes
Other Study ID Numbers: 007
Study First Received: August 9, 2013
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by ScienceBased Health:
Primary open angle glaucoma
intraocular pressure
ocular perfusion pressure
retrobulbar blood flow
retinal capillary blood flow
choroidal blood flow

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014