NCT05695027

Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine if a combination of oral nicotinamide and pyruvate (N\&P) can maintain eye health as compared to placebo while standard-of-care intraocular pressure-lowering glaucoma medications are used to treat glaucoma. A total of up to 188 participants will be enrolled and randomized 1:1 to receive N\&P or placebo for 87 weeks (20 months). Participants will be followed for a total of 91 weeks (21 months).

Detailed description

Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing or standard automated perimetry (SAP). The natural course of glaucoma includes a decline in visual function that matches optic nerve structural changes over time. Both in clinical practice and in clinical trials, individuals undergo visual field testing at regular intervals in order to define whether progressive changes have occurred as well as the rapidity of change. Visual field results are highly variable within and between sessions, partly due to its subjective nature, which ultimately depends upon the test reliability, individuals' level of experience with the test, variability due to disease severity, and, importantly, the level of individual attentiveness during the test. Therefore, numerous attempts have been made to try to optimize individuals' performance during the test. Some of the approaches reported to date are listening to classical music mitigating background noise and use of nutritional supplements. Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. The investigators are doing this research study to find out if taking nutritional supplements (vitamin B3 and pyruvate) available over- the-counter can help slow the rate of glaucomatous visual field progression compared to placebo.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	Dietary supplements - Nicotinamide and Pyruvate	Nutritional supplements
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-03-14
• Primary completion: 2026-06-01
• Completion: 2028-01-01
• First posted: 2023-01-23
• Last updated: 2025-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study