NCT07861243Completed
Unravelling the Effects of Nicotinamide/Pyrroloquinolone Quinone /Citicoline/Homotaurine Fixed Combination on Contrast Sensitivity, Quality of Life, and Reading Performance in Glaucoma
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 22 Sept 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Diseases
- Glaucoma
- NCT number
- NCT07861243
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 1 Nov 2025 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgical treatment for glaucoma or other ocular surgeries (except for cataract surgery performed more than 6 months earlier)
- Concomitant ocular diseases, previous ocular trauma, or high myopia
Other illness
- Neurodegenerative diseases of the central nervous system, dysarthria, dyslexia, psychiatric disorders
Other
- Illiteracy
- Severe-stage glaucoma (MD \< -12 dB)
- Pregnancy/breastfeeding
Who the study is looking for
- Age over 18 years
- Good knowledge of the Italian language and good reading skills
- Manifest primary open-angle glaucoma (POAG) in the early to moderate stage (MD \> -12 dB). The stage of glaucoma is determined by measuring the mean defect (MD, dB) using standard automated perimetry (HFA II/III; Carl Zeiss Meditec, Dublin, CA, USA, program 24/2).
- Patients able to provide written informed consent
- Pharmacologically controlled IOP: average values of 3 measurements (9 AM) \<18 mmHg
- Stable perimetry in the year prior to enrollment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Oftalmologica - Ospedale clinicizzato SS Annunziata di Chieti Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.