The Effects of an Antioxidant Formulation on Ocular Blood Flow

NCT01930487 | Completed Results

• 1 other identifier: 007
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  baseline and 30 days

Secondary Outcomes (43)

• Change in Ocular Perfusion Pressure

  baseline and 30 days

• Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)

  baseline and 30 days

• Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)

  baseline and 30 days

• Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)

  baseline and 30 days

• Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)

  baseline and 30 days

Study Arms (2)

supplement w/ antioxidants then placebo

EXPERIMENTAL

dietary supplement with antioxidants, followed by placebo supplement

Dietary Supplement: dietary supplement with antioxidants; Dietary Supplement: Placebo

placebo then supplement w/ antioxidants

EXPERIMENTAL

placebo supplement, followed by dietary supplement with antioxidants

Dietary Supplement: dietary supplement with antioxidants; Dietary Supplement: Placebo

Interventions

dietary supplement with antioxidants DIETARY_SUPPLEMENT

Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Also known as: Optic Nerve Formula

placebo then supplement w/ antioxidants; supplement w/ antioxidants then placebo

Placebo DIETARY_SUPPLEMENT

Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants

placebo then supplement w/ antioxidants; supplement w/ antioxidants then placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ScienceBased Health: lead

Study Sites (1)

Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Dietary Supplements; Antioxidants

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Results Point of Contact

• Title: Brent Siesky, PhD, Assistant Director
• Organization: Ocular Vascular Research Center, Indiana University School of Medicine

bsiesky@indiana.edu

317-278-0177

Study Officials

• Alon Harris, PhD

  Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2016-01

Locations

US (1)