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COMPLETED
NCT07861243
NA

Unravelling the Effects of Nicotinamide/Pyrroloquinolone Quinone /Citicoline/Homotaurine Fixed Combination on Contrast Sensitivity, Quality of Life, and Reading Performance in Glaucoma

Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara

View on ClinicalTrials.gov

Summary

Glaucoma is a chronic, progressive neuro-ophthalmic condition that leads to irreversible loss of retinal ganglion cells (RGCs) and is the second leading cause of blindness worldwide. It is associated with elevated intraocular pressure (IOP), but many patients continue to experience vision loss even with controlled IOP. Mitochondrial dysfunction is a key mechanism in RGC damage, leading to interest in neuroprotective treatments. Various compounds like citicoline (CIT), homotaurine (HOMO), vitamin B3 (nicotinamide), and pyrroloquinoline quinone (PQQ) have shown potential in protecting RGCs, improving mitochondrial function, and reducing oxidative stress. This study aims to compare the effects of a combination supplement (NEUPROZIN MITO) containing CIT, HOMO, NAM, and PQQ with CIT alone (OPTIGEN) on contrast sensitivity, quality of life, and reading speed in patients with primary open-angle glaucoma (POAG) and controlled IOP. The study is a randomized, cross-over trial with two treatment groups, and outcomes will include changes in visual function, quality of life, and reading performance over 8 months. The sample size calculation suggests enrolling 44 patients to detect a clinically significant difference. This research will assess the effectiveness of mitochondrial-targeted therapies for glaucoma patients with controlled IOP.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2025-11-01

Completion Date

2026-02-01

Last Updated

2026-10-06

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

Citicoline 500 MG (Optigen) for 4 months

one citicoline tablet per day for 4 months

DIETARY_SUPPLEMENT

citicoline 500 mg + nicotinamide 54 mg + PQQ 5 mg + Homotaurine 50 mg fixed combination tablet (Neuprozin mito)

one fixed combination tablet per 4 months

Locations (1)

Clinica Oftalmologica - Ospedale clinicizzato SS Annunziata di Chieti

Chieti, Italy, Italy