Clinical trial NCT04784234: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: primary open angle glaucoma
visual field loss
vision enhancement
GlaucoCetin
Neuroprotection
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Guardian Health Sciences, Inc.
First posted: 2021-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Field Mean Deviation
timeFrame: 3 hour examinations during a 6 month period
Secondary outcomes:
measure: Perceived Quality of Life Improvement
timeFrame: 20 minute questionnaires during a 6 month period
measure: Perceived Quality of Life Improvement measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
timeFrame: 20 minute questionnaires during a 6 month period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital, Glaucoma Research Center
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: Natasha N Kolomeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: