Status:
TERMINATED
Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin
Lead Sponsor:
Wills Eye
Collaborating Sponsors:
Guardian Health Sciences, Inc.
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
40-80 years
Phase:
NA
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 opt...
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 secondar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04784234
Start Date
February 1 2021
End Date
October 27 2022
Last Update
December 23 2025
Active Locations (1)
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1
Wills Eye Hospital, Glaucoma Research Center
Philadelphia, Pennsylvania, United States, 19107