Study of Neurotidine® Intake on Life Quality of Patients With Glaucoma

NCT ID: NCT04046809

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-13
• Study Completion Date: 2022-01-24

Brief Summary

The purpose for the study consists in the assessment of the role of Neurotidine® (citicoline oral solution) on the dopaminergic pathway and particularly its potential implications on psychophysical performance and quality of life. Other objectives are the assessment of the tolerability and safety of Neurotidine®.

Detailed Description

Primary open angle glaucoma is a chronic progressive neurodegenerative disease and the only proven effective therapy involves reduction of intraocular pressure (IOP). Although treatment effect is quite large, a significant proportion of patients show disease progression with apparently controlled IOP. Given the similarities with other neurodegenerative diseases - particularly in the mechanisms of cell death -neuroprotective treatments have been tried also in glaucoma. Interesting results from experimental studies and weak evidence from human glaucoma trials have been published in recent years. Citicoline is one of the promising molecules with a putative neuroprotective action and has been tried on patients with a number of neurodegenerative diseases with encouraging results. Pilot studies on glaucomatous patients showed a possible effect of citicoline in reducing progression of visual field changes, though these findings need to be confirmed by larger randomized clinical trials.

The aim of this randomized, double-masked, placebo-controlled, cross-over study is to test whether the intake of Neurotidine® (citicoline free acid in oral solution) can be associated with an improvement of quality of life in patients with glaucoma.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Treatment

500 ml oral solution containing citicoline free acid 50 mg/ml.

Group Type: EXPERIMENTAL

Food for special medical purposes: Neurotidine®

Intervention Type: OTHER

Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months).

Administration at a dosage of 10 ml in the morning.

Placebo

500 ml oral solution indistinguishable from active product in appearance and taste

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months).

Administration at a dosage of 10 ml in the morning.

Interventions

Food for special medical purposes: Neurotidine®

Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months).

Administration at a dosage of 10 ml in the morning.

Intervention Type: OTHER

Placebo

Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months).

Administration at a dosage of 10 ml in the morning.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients must meet all the following criteria to be eligible for the study:

• Signed written informed consent.
• Age ≥ 18 years.
• Patients with bilateral open-angle glaucoma (OAG). PEX and pigmentary glaucoma will be included.
• Controlled IOP
• Patients with moderate damage in the better eye, with mean deviation from normal value (MD) ranging from -6 to -12 dB in the 6 months prior to enrollment. At the screening assessment, MD must range from -5 to -13 dB.

Glaucoma definition will be based on visual field (VF) damage (24-2, SITA standard strategy) corresponding to glaucomatous changes at the optic nerve head. Values of IOP will not be an inclusion criterion, though a "controlled IOP" based on the clinician's judgement will be required.

Exclusion Criteria

Patients must meet none of the following criteria to be eligible for the study:

• Single-eyed patients (visual acuity <0.1 in one eye).
• Patients without the psychophysical requirements to adequately participate and complete the trial.
• Patients with chronic angle-closure glaucoma (CACG) or other types of glaucoma.
• Patients with other ocular comorbidities interfering with the correct assessment of the glaucomatous damage to the VF.
• Patients who have undergone surgery within 6 months.
• Patients taking other potential neuroprotectors, including topical, competing with Neurotidine®.
• Patients with Parkinson's disease, dementia or a diagnosis of stroke in the last 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omikron Italia S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Rossetti, Prof.

Role: PRINCIPAL_INVESTIGATOR

Presidio Ospedale San Paolo

Locations

University Hospitals Leuven

Leuven, , Belgium

Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki

Thessaloniki, , Greece

Presidio Ospedale San Paolo

Milan, MI, Italy

Fondazione PTV Policlinico Tor Vergata

Roma, , Italy

CTIG - Teknon

Barcelona, , Spain

Countries

Belgium; Greece; Italy; Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-002187-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NEUQOL2018

Identifier Type: -

Identifier Source: org_study_id