Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

Sponsor

Wills Eye (Other)

Overall Status

Recruiting

CT.gov ID

NCT04784234

Collaborator

Guardian Health Sciences, Inc. (Other)

100

Enrollment

Location

Arms

34.9

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is looking at changes in vision and visual function before and after a six month trial of a daily medical food called GlaucoCetin, formulated with ingredients to support and protect the optic nerve cells. Open angle glaucoma patients will be randomized to receive either a placebo or the medical food for 6 months. We hope to learn if this medical food can improve the vision of our glaucoma patients and to report the findings obtained to the general public.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma	Dietary Supplement: GlaucoCetin Other: Placebo	N/A

Detailed Description

The primary objective of this study is to evaluate the improvement in vision and visual function during a 6 month trial of GlaucoCetin versus placebo in patients with open angle glaucoma. The secondary objective is to evaluate change in quality of life, electrophysiologic response, and contrast sensitivity.

Procedures involved during participation include review of medical/ocular history, best corrected visual acuity, multiple Humphrey visual field testing 24-2 and 10-2 , Octopus G-Top, pattern electroretinogram (PERG), ocular coherence tomography (OCT), ocular coherence tomography angiography (OCTA), intraocular pressure (IOP), contrast sensitivity testing (CSV-1000), corneal hysteresis, biomicroscopy, fundus exam, disc photos, and serum testing.

To evaluate quality of life, included in testing is Compressed Assessment of Ability Related to Vision (CAARV). Responses to multiple surveys regarding vision related quality of life (GQL-15, Glaucoma Symptom Scale (GSS), National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)) and diet (NHANES Dietary Screener) will be captured. Number of daily steps will be monitored at 2 intervals during the study using pedometers.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study aims to enroll 50 patients within each intervention arm (GlaucoCetin vs Placebo). Within the intervention arm there will be one group with Central visual field defects and one group with Peripheral visual field defects.Study aims to enroll 50 patients within each intervention arm (GlaucoCetin vs Placebo). Within the intervention arm there will be one group with Central visual field defects and one group with Peripheral visual field defects.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Masking of GlaucoCetin and identical Placebo was provided by Guardian Health Sciences, Inc. Labeling has been conducted by non-clinical study team personnel in Glaucoma Research Center at Wills Eye Hospital.

Primary Purpose:

Treatment

Official Title:

A Prospective Randomized Controlled Trial of GlaucoCetin vs Placebo in Glaucoma Patients With Visual Field Loss.

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: GlaucoCetin Peripheral Group Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.	Dietary Supplement: GlaucoCetin GlaucoCetin, a medical food in capsule form, is FDA regulated and includes ingredients that have been shown to support and protect mitochondrial function of retinal ganglion cells. GlaucoCetin consists of a mixture of Curcumin, N-Acetyl Cysteine, Ginkgo Biloba Extract, Alpha-lipoic Acid, Citicoline, Grape Seed Extract, Green Tea Extract, and Coenzyme Q10. Additional ingredients include L-Taurine, Niacinamide, Biotin, Natural Astaxanthin, Fisetin, Quercetin, Luteolin, Proprietary Dragonberry Flavor Complex, Monk Fruit, Bitter Blocker Natural Flavor, Citric Acid, Silica Dioxide, Fibersol-2, L-Leucine. Many of these are known anti-inflammatory and antioxidant ingredients. A 6 month supply of capsules, made for this study, will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.
Placebo Comparator: Placebo Peripheral Group Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.	Other: Placebo The placebo is an identical capsule to the GlaucoCetin, made for this study, with no nutritional value. A 6 month supply of capsules will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.
Active Comparator: GlaucoCetin Central Group Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.	Dietary Supplement: GlaucoCetin GlaucoCetin, a medical food in capsule form, is FDA regulated and includes ingredients that have been shown to support and protect mitochondrial function of retinal ganglion cells. GlaucoCetin consists of a mixture of Curcumin, N-Acetyl Cysteine, Ginkgo Biloba Extract, Alpha-lipoic Acid, Citicoline, Grape Seed Extract, Green Tea Extract, and Coenzyme Q10. Additional ingredients include L-Taurine, Niacinamide, Biotin, Natural Astaxanthin, Fisetin, Quercetin, Luteolin, Proprietary Dragonberry Flavor Complex, Monk Fruit, Bitter Blocker Natural Flavor, Citric Acid, Silica Dioxide, Fibersol-2, L-Leucine. Many of these are known anti-inflammatory and antioxidant ingredients. A 6 month supply of capsules, made for this study, will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.
Placebo Comparator: Placebo Central Group Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.	Other: Placebo The placebo is an identical capsule to the GlaucoCetin, made for this study, with no nutritional value. A 6 month supply of capsules will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.

Outcome Measures

Primary Outcome Measures

Visual Field Mean Deviation [3 hour examinations during a 6 month period]
Improvement in visual field mean deviation, measured in decibels, will be compared before, during and after a 6 month trial of daily GlaucoCetin vs Placebo capsules.

Secondary Outcome Measures

Perceived Quality of Life Improvement [20 minute questionnaires during a 6 month period]
Improvement in participants perceived vision-related quality of life (GQL-15, Glaucoma Symptom Scale (GSS)
Perceived Quality of Life Improvement measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) [20 minute questionnaires during a 6 month period]
Improvement in participants perceived vision-related quality of life ( National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25))

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age of 40 to 80 years
Bilateral open angle glaucoma with reliable visual field defects (at least one eye with mean deviation (MD) between -4.00 to -10.00 decibels (dB) on Humphrey Visual Field 24-2.
Group 1 (Peripheral): meets 1 hodapp-parrish-anderson (HPA) criteria for defect (3 contiguous points depressed on the pattern standard deviation (PSD) p <5%, one of which is depressed at p <1% level), and does not meet below paracentral criteria for Group 2.
Group 2 (Central): at least 1 paracentral point repeatedly depressed at p<1% on 24-2. Also meets the HAP criteria outlined above.
Visual acuity 20/40 or better in each eye
Intraocular Pressure (IOP) controlled at 2 measurements >3 months
Clear media

Exclusion Criteria:

Known bleeding disorder
History of epilepsy or on anti-seizure medication
Uncontrolled hypertension or diabetes
Uncontrolled IOP
Eye pathology leading to inaccurate IOP measurement
Visually significant retinal pathology affecting vision in past or active (such as diabetic retinopathy or age related macular degeneration)
Non-glaucomatous optic neuropathy
Visually significant cataract (worse then 2+ cataract, or what is determined visually clinically significant by physician)
History of ocular trauma
Selective laser trabeculoplasty or laser procedure within past 3 months
Cataract surgery within past 3 months
Incisional glaucoma surgery within 6 months
Current use of nitroglycerin
Current use of antiplatelet therapy besides aspirin (such as clopidogrel) or anticoagulation (such as warfarin)
Current use of systemic steroids or immunomodulating agents such as methotrexate.
Sensitivity or allergy to any ingredients in GlaucoCetin: Curcumin, L-Taurine, N-Acetyl Cysteine, Niacinamide, Ginkgo Biloba, Lipoic Acid, Citicoline, Grape Seed Extract, Green Tea Leaf Extract, Coenzyme Q10, Biotin, Natural Astaxanthin, flavonoid complex containing Fisetin, Quercetin, and Luteolin
Recent change in systemic medications or vitamins
Use of Biotin, Ginkgo Biloba, Citicoline within past 3 months (or any other Glaucocetin ingredients within 1 month)
Unreliable visual fields
Unwilling to take supplement or placebo for 6 months