Clinical trial NCT01930487: The Effects of an Antioxidant Formulation on Ocular Blood Flow
Official title: The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: ScienceBased Health
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 47
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)
timeFrame: baseline and 30 days
measure: Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)
timeFrame: baseline and 30 days
Secondary outcomes:
measure: Change in Ocular Perfusion Pressure
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM
timeFrame: baseline and 30 days
measure: Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM
timeFrame: baseline and 30 days
measure: Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
timeFrame: baseline and 30 days
measure: Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
timeFrame: baseline and 30 days
measure: Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
timeFrame: baseline and 30 days
measure: Change in Ocular Perfusion Pressure - DM
timeFrame: baseline and 30 days
measure: Change in Ocular Perfusion Pressure - No DM
timeFrame: baseline and 30 days
measure: Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM
timeFrame: baseline and 30 days
measure: Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM
timeFrame: baseline and 30 days
measure: Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM
timeFrame: baseline and 30 days
measure: Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM
timeFrame: baseline and 30 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
name: Alon Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References: