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| Name | Class |
|---|---|
| Hanlim Pharm. Co., Ltd. | INDUSTRY |
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Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide(Mitovita) | Experimental | 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) |
|
| Placebo | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide(Mitovita) | Other | Nicotinamide(VitaminB3) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group) | Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks | Baseline,12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group) | Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks | Baseline, 6, 12, 18, 24weeks |
| Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seungsoo Rho, MD, PhD | Contact | 82-10-9260-3173 | harryrho@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seungsoo Rho, MD, PhD | CHA Bundang Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA University Bundang Medical Center | Recruiting | Seongnam | Bundang-gu | 13497 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41167798 | Derived | Ha A, Kim YK, Lee CK, Williams PA, Morgan JE, Shin YI, Kim E, Kim M, Rho S. Effects of nicotinamide supplementation in normal-tension glaucoma: a crossover placebo-controlled randomised clinical trial. Br J Ophthalmol. 2026 Mar 20;110(4):417-424. doi: 10.1136/bjo-2025-328096. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Placebo |
| Other |
Placebo |
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Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks |
| Baseline, 6, 12, 18, 24weeks |
| Change of mean deviation as measured by Visual Fields (intra-group) | Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks | Baseline, 12weeks, 24weeks |
| Change of mean deviation as measured by Visual Fields (Group1 VS Group2) | Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks | Baseline, 12weeks, 24weeks |
| Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2) | Change of Pointwise sensitivity in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total/pattern deviation | Baseline, 12weeks, 24weeks |
| Change of visual field sensitivity number of locations | Change of visual field sensitivity number of locations in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total, pattern deviation | Baseline, 12weeks, 24weeks |