The Effects of an Antioxidant Formulation on Ocular Blood Flow

NCT ID: NCT01930487

Last Updated: 2016-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

supplement w/ antioxidants then placebo

dietary supplement with antioxidants, followed by placebo supplement

Group Type: EXPERIMENTAL

dietary supplement with antioxidants

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

placebo then supplement w/ antioxidants

placebo supplement, followed by dietary supplement with antioxidants

Group Type: EXPERIMENTAL

dietary supplement with antioxidants

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

dietary supplement with antioxidants

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Optic Nerve Formula

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ScienceBased Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alon Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

007

Identifier Type: -

Identifier Source: org_study_id