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

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 2026 to Aug 2027v10
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 3 of 3 sitesv9 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  3. Primary completion date: Jan 2025 to Jun 2026v8
  4. Enrollment target: 188 to 250 Study sites: 2 to 3 · Collaborators expanded, about 2 wordsv7 Show 2 more changesShow less
    • Study sites: 2 to 3
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study Identification, Study Status, Oversight, Eligibilityv6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria shortened, about 16 words Study sites revised (2)v5 Show 1 more changeShow less
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints revised (2) Eligibility criteria revisedv4 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary endpoints revised (2) Primary completion date: Jan 15, 2025 to Jan 2025 · Completion date: Jan 15, 2028 to Jan 2028 · Start date changed from estimate of Feb 15, 2023 to Mar 14, 2023 · 2 morev3 Show 5 more changesShow less
    • Primary completion date: Jan 15, 2025 to Jan 2025
    • Completion date: Jan 15, 2028 to Jan 2028
    • Start date changed from estimate of Feb 15, 2023 to Mar 14, 2023
    • Eligibility criteria shortened, about 18 words
    • Study description shortened, about 276 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Jan 15, 2023 to Feb 15, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05695027
Lead Sponsor Columbia University
Collaborators: Stanford University
Conditions Primary Open Angle Glaucoma
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov