The Effects of an Antioxidant Formulation on Ocular Blood Flow

Primary Open Angle Glaucoma Clinical Trial

Official title:

The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930487
• Other study ID #: 007
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: January 28, 2016
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: ScienceBased Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Dietary Supplement:
• dietary supplement with antioxidants
Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
• Placebo
Placebo Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants

Locations

Country	Name	City	State
United States	Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
ScienceBased Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retinal capillary blood flow	retinal capillary blood flow in arbitrary units.	30 days	No
Primary	Retrobulbar blood flow velocities and vascular resistance	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).	30 days	No
Secondary	Ocular perfusion pressure	2/3 Mean arterial pressure - intraocular pressure	30 days	No
Secondary	Ocular pulse amplitude	a measure used to estimate choroid blood flow in bulk	30 days	No
Secondary	Outcomes 1-4 above	Examine hemodynamic measures in subgroup of POAG subjects with type 2 diabetes vs. POAG subjects without type 2 diabetes	30 days	No