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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
CHA University Bundang Medical Center
RECRUITING
Seongnam
Contact Information
Primary
Seungsoo Rho, MD, PhD
harryrho@gmail.com
82-10-9260-3173
Time Frame
Start Date: 2022-09-16
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 80
Treatments
Experimental: 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)
Placebo_comparator: 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)
Sponsors
Collaborators: Hanlim Pharm. Co., Ltd.
Leads: CHA University

This content was sourced from clinicaltrials.gov

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