Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients
NCT ID: NCT06078605
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-09-16
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Nicotinamide(Mitovita)
Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID)
Nicotinamide(Mitovita)
Nicotinamide(VitaminB3)
Placebo
Group1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID)
Placebo
Placebo
Interventions
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Nicotinamide(Mitovita)
Nicotinamide(VitaminB3)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.
3. Intraocular pressure (IOP) \>/= 8mmHg and \< 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit
4. Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(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 Criteria
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 electroretinogram parameter, or with visual field defects(Ischemic optic neuropathy, Proliferative diabetic 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 the screening 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.
19 Years
ALL
No
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
CHA University
OTHER
Responsible Party
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Principal Investigators
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Seungsoo Rho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHA Bundang Medical Center
Locations
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CHA University Bundang Medical Center
Seongnam, Bundang-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NRG1
Identifier Type: -
Identifier Source: org_study_id
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