The Effects of an Antioxidant Formulation on Ocular Blood Flow

ScienceBased Health

Status: Completed

Conditions: Primary Open Angle Glaucoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01930487

007

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups

supplement w/ antioxidants then placebo

Experimental group

Description:

dietary supplement with antioxidants, followed by placebo supplement

Treatment:

Dietary Supplement: dietary supplement with antioxidants

Dietary Supplement: Placebo

placebo then supplement w/ antioxidants

Experimental group

Description:

placebo supplement, followed by dietary supplement with antioxidants

Treatment:

Dietary Supplement: dietary supplement with antioxidants

Dietary Supplement: Placebo