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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
- In the case of participants receiving glaucoma treatment drugs, the investigatorjudges that the intraocular pressure remains constant for at least 1 year.
- Intraocular pressure (IOP) >/= 8mmHg and < 18mmHg in each eye using Goldmannapplanation tonometry prior to the screening visit
- Adult participants diagnosed and treated for early-moderate glaucoma (VF meandeviation(MD) ≥-12 dB)
- Have performed a reliable visual field in the last year, with <33% fixation losses,false positives and false negatives.
- Written consent voluntarily to participate in this clinical trial.
Exclusion
Exclusion Criteria:
- Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
- BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25)or less.
- Patients who have medical history of ocular inflammation
- Patients with any ocular/systemic conditions that may affect electroretinogramparameter, or with visual field defects(Ischemic optic neuropathy, Proliferativediabetic retinopathy, Macular degeneration etc.)
- Patients who have plans to intraocular surgery within the clinical trial period.
- Patients with a history of significant ocular trauma within 6 months prior to thescreening visit
- Pregnant or lactating women.
- A person who disagrees to contraception during a clinical trial period.
- Patients with a history of malignancy within 5 years prior to the screening visit.
- 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
Connect with a study center
CHA University Bundang Medical Center
Seongnam, Bundang-gu 13497
Korea, Republic ofActive - Recruiting

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