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Sponsor study identifier
interventional
44
1 country
1
Study Start
November 1, 2025
Actual (reported)Primary Completion
November 1, 2025
Actual (reported)Study Completion
February 1, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2026
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2025
Actual (reported)November 1, 2025
Actual (reported)February 1, 2026
Actual (reported)September 22, 2026
Actual (reported)October 6, 2026
Actual (reported)Unravelling the effects of Nicotinamide/Pyrroloquinolone Quinone /Citicoline/Homotaurine fixed combination on reading performance in glaucoma
Evaluate whether the intake of NEUPROZIN MITO and OPTIGEN induces changes in reading speed in patients with pharmacologically controlled POAG, and whether there are differences between the two groups at 4 and 8 months. Reading speed is assessed using the MNREAD App. The MNREAD chart uses standardized sentences consisting of 10 words (60 characters) to determine reading speed across print sizes that decrease logarithmically in 0.1 log-unit steps.
From enrollment to the end of treatment at 8 months
Unravelling the effects of Nicotinamide/Pyrroloquinolone Quinone /Citicoline/Homotaurine fixed combination on contrast sensitivity,
Evaluate whether the intake of NEUPROZIN MITO and OPTIGEN induces changes in contrast sensitivity in patients with pharmacologically controlled POAG, and whether there are differences between the two groups at 4 and 8 months. SPARCS test is a contrast sensitivity test. The range of contrast tested is from 100% to 0.45% (log contrast sensitivity from 0.00 to 2.35), with an approximately 0.15-log-unit decrease between contrast levels.
From enrollment to the end of treatment at 8 months
1. Unravelling the effects of Nicotinamide/Pyrroloquinolone Quinone /Citicoline/Homotaurine fixed combination on quality of life.
Evaluate whether the intake of NEUPROZIN MITO and OPTIGEN induces changes in quality of life in patients with pharmacologically controlled POAG, and whether there are differences between the two groups at 4 and 8 months. Assessment of quality of life using the "Glaucoma Quality of Life 15" (GQL-15). This test consists of 15 questions, each assigned a score. The normal score ranges from 0 to 75 points, while higher scores indicate a poorer quality of life.
From enrollment to the end of treatment at 8 weeks
effects of neuroprotection correlated to glaucoma stage
From enrollment to the end of treatment at eight months
Patients with stable mild to moderate glaucoma, as assessed perimetrically and tonometrically, will be administered Neuprozin Mito for 4 months. After this period, Neuprozin Mito will be discontinued, and patients will be administered Optigen for an additional 4 months. At baseline, 4 months, and 8 months, the following assessments will be performed: best corrected visual acuity (VA) for both distance and near, IOP, 24-2 visual field (Humphrey Field Analyzer (HFA), Zeiss) with determination of MD, PSD, VFI, GHT; OCT to study the peripapillary retinal nerve fiber layer (RNFL) thickness and the macular ganglion cell complex (GCL-IPL) thickness (Cirrus 6000, Carl Zeiss Meditec); contrast sensitivity using the Spaeth/Richman contrast sensitivity (SPARCS) test (on computer support); quality of life assessment using the Glaucoma Quality of Life 15 (GQL-15) questionnaire; and reading performance using the Italian version of the MNREAD test.
one citicoline tablet per day for 4 months
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
citicoline 500 mg + nicotinamide 54 mg + PQQ 5 mg + Homotaurine 50 mg fixed combination tablet (Neuprozin mito)
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordClinica Oftalmologica - Ospedale clinicizzato SS Annunziata di Chieti
Chieti, Italy, Italy
44 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2026
First Posted
October 6, 2026
Study Start
November 1, 2025
Actual (reported)Patients with stable mild to moderate glaucoma, as assessed perimetrically and tonometrically, will be administered Optigen for 4 months. After this period, Optigen will be discontinued, and patients will be administered Neuprozin mito for an additional 4 months. At baseline, 4 months, and 8 months, the following assessments will be performed: best corrected visual acuity (VA) for both distance and near, IOP, 24-2 visual field (Humphrey Field Analyzer (HFA), Zeiss) with determination of MD, PSD, VFI, GHT; OCT to study the peripapillary retinal nerve fiber layer (RNFL) thickness and the macular ganglion cell complex (GCL-IPL) thickness (Cirrus 6000, Carl Zeiss Meditec); contrast sensitivity using the Spaeth/Richman contrast sensitivity (SPARCS) test (on computer support); quality of life assessment using the Glaucoma Quality of Life 15 (GQL-15) questionnaire; and reading performance using the Italian version of the MNREAD test.
one fixed combination tablet per 4 months
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Primary Completion
November 1, 2025
Actual (reported)Study Completion
February 1, 2026
Actual (reported)Last Updated
October 6, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the results reported in the publication will be available from the corresponding author upon reasonable request, subject to applicable ethical and regulatory requirements.
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Source: ClinicalTrials.gov.
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