TerminatedNot Applicable

Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

Stopped: company was bought and discontinued producing supplement

United States12 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Field Mean Deviation

Timeframe: 3 hour examinations during a 6 month period

Trial details

NCT IDNCT04784234

SponsorWills Eye

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-27

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials