Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma

April 29, 2025 updated by: Gemma Caterina Maria Rossi, Fondazione IRCCS Policlinico San Matteo di Pavia

Effect of the Fixed Combination Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram in Well Controlled Primary Open Angle Glaucoma: A Multicenter, Prospective, Randomized, Single Blind, Cross-over Study

the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70121
        • Dario Sisto
      • Brindisi, Italy, 72100
        • Alberto Mavilio
      • Torino, Italy, 10121
        • Teresa Rolle
    • PV
      • Pavia, PV, Italy, 27100
        • Gemma Caterina Maria Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age between 40 and 75 years;
  • diagnosis of primary OAG (POAG) from, at least, 3 years;
  • visual acuity > 0.7 (7/10) decimals;
  • refractive error < 5 D (spheric) and < 2D (toric);
  • transparent diopter means (cornea and lens);
  • controlled IOP (<18 mmHg, morning value) with beta-blockers and prostaglandin analogues as monotherapy or as associative therapy (fixed or unfixed);
  • stable IOP<18 mmHg in the last 2 years;
  • stable and unchanged topical therapy in the last 6 months;
  • stable disease in the last 2 years (no more than -1 dB/year at MD of visual field);
  • at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm -SITA- Standard) per year in the last 2 years;
  • early to moderate visual field defect (MD <12 dB);
  • electrophysiological (PERG) parameters alterations similar to glaucomatous pathology;
  • written consent to participate to study procedures and data utilization in an anonymous form

Exclusion Criteria:

  • ocular hypertension with normal optic nerve and visual field; angle closure glaucoma;
  • congenital glaucoma; secondary glaucoma; normal tension glaucoma;
  • history of recurrent uveitis/scleritis/herpes infection;
  • pregnancy and breastfeeding;
  • contraindication to Citicoline and/or Homotaurine
  • contraindication to beta-blockers and prostaglandine analogues
  • topical therapy with Brimonidine monotherapy or fixed combination (with timolol or brinzolamide)
  • topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment
  • systemic therapies affecting patients' performance in visual field examination (sedatives);
  • glaucomatous scotomas within 10 degree from fixation
  • any condition limiting the patient's ability to participate in the study;
  • other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy;
  • other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, ALS, MS) or pituitary disorders;
  • cerebral ischemia in the last 2 years
  • any change in topical therapy in the 6 months prior to enrollment or during the study period concomitant participation to another clinical trial
  • any previous filtering and/or retinal surgery;
  • cataract surgery in the last 6 months;
  • any previous laser treatment for glaucoma in the last 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: standard of care + citicoline plus homotaurine (CIT/HOMO)
CIT/HOMO was supplemented for 4 months to the standard of care (SOC, i.e. topical intraocular pressure, IOP, lowering medication)
Dietary supplement: Citicoline 500 mg plus Homotaurine 50 mg
Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy
Other Names:
  • CIT/HOMO
  • Neuprozin®
No Intervention: standard of care
only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
Time Frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
changes in amplitude (microVolt)
4 months of therapy 2 months of wash out 4 months without adding therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity
Time Frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
changes in visual acuity (decimals)
4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field
Time Frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters
4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life
Time Frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)
4 months of therapy 2 months of wash out 4 months without adding therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Policlinico San Matteo di Pavia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: gemma caterina m Rossi, Irccs Fondazione Policlinico San Matteo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be published on peer review journal

IPD Sharing Time Frame

upon publication

IPD Sharing Access Criteria

actually not available

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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