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Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

Primary Purpose

Primary Open Angle Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GlaucoCetin
Placebo
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring primary open angle glaucoma, visual field loss, vision enhancement, GlaucoCetin, Neuroprotection

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wills Eye Hospital, Glaucoma Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

GlaucoCetin Peripheral Group

Placebo Peripheral Group

GlaucoCetin Central Group

Placebo Central Group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Visual Field Mean Deviation
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
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)
Improvement in participants perceived vision-related quality of life ( National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25))

Full Information

First Posted
March 2, 2021
Last Updated
June 30, 2022
Sponsor
Wills Eye
Collaborators
Guardian Health Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04784234
Brief Title
Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin
Official Title
A Prospective Randomized Controlled Trial of GlaucoCetin vs Placebo in Glaucoma Patients With Visual Field Loss.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Guardian Health Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
primary open angle glaucoma, visual field loss, vision enhancement, GlaucoCetin, Neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GlaucoCetin Peripheral Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Peripheral Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
GlaucoCetin Central Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Central Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
GlaucoCetin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Field Mean Deviation
Description
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.
Time Frame
3 hour examinations during a 6 month period
Secondary Outcome Measure Information:
Title
Perceived Quality of Life Improvement
Description
Improvement in participants perceived vision-related quality of life (GQL-15, Glaucoma Symptom Scale (GSS)
Time Frame
20 minute questionnaires during a 6 month period
Title
Perceived Quality of Life Improvement measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
Description
Improvement in participants perceived vision-related quality of life ( National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25))
Time Frame
20 minute questionnaires during a 6 month period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha N Kolomeyer, MD
Phone
215-928-3123
Email
nkolomeyer@willseye.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne Molineaux, COA
Phone
12158254713
Email
jmolineaux@willseye.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha N Kolomeyer, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital, Glaucoma Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Molineaux
Phone
215-825-4713
Email
jmolineaux@willseye.org
First Name & Middle Initial & Last Name & Degree
Glaucoma Research Center
Phone
215-928-3123
First Name & Middle Initial & Last Name & Degree
Jonathan S Myers, MD
First Name & Middle Initial & Last Name & Degree
M. Reza Razeghinejad, MD
First Name & Middle Initial & Last Name & Degree
Daniel Lee, MD
First Name & Middle Initial & Last Name & Degree
Aakriti Shukla, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

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