Status:
UNKNOWN
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients
Lead Sponsor:
CHA University
Collaborating Sponsors:
Hanlim Pharm. Co., Ltd.
Conditions:
Glaucoma
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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
Detailed Description
Not provided
Eligibility Criteria
Inclusion
- Adult(Male or Female) over 19 years who were diagnosed with glaucoma.
- In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.
- Intraocular pressure (IOP) \>/= 8mmHg and \< 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit
- Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(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
- 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 electroretinogram parameter, or with visual field defects(Ischemic optic neuropathy, Proliferative diabetic 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 the screening 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.
Key Trial Info
Start Date :
September 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06078605
Start Date
September 16 2022
End Date
June 30 2024
Last Update
October 12 2023
Active Locations (1)
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1
CHA University Bundang Medical Center
Seongnam, Bundang-gu, South Korea, 13497