Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Last updated: October 9, 2023
Sponsor: CHA University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Placebo

Nicotinamide(Mitovita)

Clinical Study ID

NCT06078605
NRG1
  • Ages > 19
  • All Genders

Study Summary

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
  2. In the case of participants receiving glaucoma treatment drugs, the investigatorjudges that the intraocular pressure remains constant for at least 1 year.
  3. Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmannapplanation tonometry prior to the screening visit
  4. Adult participants diagnosed and treated for early-moderate glaucoma (VF meandeviation(MD) ≥-12 dB)
  5. Have performed a reliable visual field in the last year, with <33% fixation losses,false positives and false negatives.
  6. Written consent voluntarily to participate in this clinical trial.

Exclusion

Exclusion Criteria:

  1. Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
  2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25)or less.
  3. Patients who have medical history of ocular inflammation
  4. Patients with any ocular/systemic conditions that may affect electroretinogramparameter, or with visual field defects(Ischemic optic neuropathy, Proliferativediabetic retinopathy, Macular degeneration etc.)
  5. Patients who have plans to intraocular surgery within the clinical trial period.
  6. Patients with a history of significant ocular trauma within 6 months prior to thescreening visit
  7. Pregnant or lactating women.
  8. A person who disagrees to contraception during a clinical trial period.
  9. Patients with a history of malignancy within 5 years prior to the screening visit.
  10. Patients that other researchers are determined inadequately.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
September 16, 2022
Estimated Completion Date:
June 30, 2024

Study Description

Not provided

Connect with a study center

  • CHA University Bundang Medical Center

    Seongnam, Bundang-gu 13497
    Korea, Republic of

    Active - Recruiting

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