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

Omikron Italia

Status

Completed

Conditions

Glaucoma

Treatments

Other: Placebo

Other: Food for special medical purposes: Neurotidine®

Study type

Interventional

Funder types

Industry

Identifiers

NCT04046809

2018-002187-11 (EudraCT Number)

NEUQOL2018

Details and patient eligibility

About

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®.

Full 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.

Enrollment

155 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.