The Effects of an Antioxidant Formulation on Ocular Blood Flow

This study is currently recruiting participants.
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

August 9, 2013
October 23, 2013
August 2013
June 2015   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01930487 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Effects of an Antioxidant Formulation on Ocular Blood Flow
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Primary Open Angle Glaucoma
  • 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: dietary supplement with antioxidants
    Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract
    Interventions:
    • Dietary Supplement: dietary supplement with antioxidants
    • Dietary Supplement: Placebo
  • Experimental: placebo
    Placebo identical in appearance to active
    Interventions:
    • Dietary Supplement: dietary supplement with antioxidants
    • Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact: Brent A. Siesky, PhD 317-278-0177 bsiesky@indiana.edu
Contact: Alon Harris, PhD 317-278-0177 alharris@indiana.edu
United States
 
NCT01930487
007
No
ScienceBased Health
ScienceBased Health
Not Provided
Principal Investigator: Alon Harris, PhD Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
ScienceBased Health
October 2013

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