Nicotinamide and Pyruvate for Open Angle Glaucoma: A Randomized Clinical Study
NCT05695027 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2025-11-12
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).
Conditions
- Primary Open Angle Glaucoma
Interventions
- DRUG
-
Dietary supplements - Nicotinamide and Pyruvate
Nutritional supplements
- DRUG
-
Placebo
Sponsors & Collaborators
- collaborator OTHER
- lead OTHER
Principal Investigators
-
Aakriti G. Shukla, MD · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-14
- Primary Completion
- 2026-06-30
- Completion
- 2028-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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