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Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in Glaucoma

NCT06431113 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-01

No results posted yet for this study

Summary

The goal of this clinical trial is to examine the effect of the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) on pattern electroretinogram (PERG) in patients with primary open angle glaucoma on well controlled intraocular pressure It will also learn about the safety of this fixed combination. The main questions it aims to answer are:

Does the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) improve PERG amplitude and/or latency? Does the fixed combination act as neuromodulator in glaucoma patients based on electrophysiology? Does the fixed combination improve quality of life of glaucoma patients? Does the fixed combination have any effect on optical coherence tomography (OCT)?

Researchers will compare the fixed combination Citicoline 500 mg, Homotaurine 50 mg, Pyrroloquinoline quinone (PQQ) disodium salt (Neuprozin Mito®) to citicoline 800 mg to see if the fixed combination works better than citicoline alone as neuroprotective agent in glaucoma.

Participants will:

Take the fixed combination or citicoline alone every day for 4 months After 4 months patients will be crossed over to the other treatment for 4 months.

Visit the clinic at enrollment and once every 4 months (at month 4 and at month 8) for checkups and tests (visual field, OCT, PERG and quality of life questionnaire)

Conditions

Interventions

COMBINATION_PRODUCT

Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )

treatment for 4 months and then cross over to the other therapy

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER

  • University of Roma La Sapienza

    collaborator OTHER

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Ciro Costagliola, MD · Federico II University eye Clinic, Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-27
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06431113 on ClinicalTrials.gov