Clinical trial NCT04046809: Study of Neurotidine® Intake on Life Quality of Patients With Glaucoma
Official title: Effect of Neurotidine® (Citicoline Free Acid in Oral Solution) on Quality of Life in Patients With Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Omikron Italia S.r.l.
Sponsor class: INDUSTRY
First posted: 2019-08-06
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The mean change of "intra-patient" global score of the Visual Functioning Questionnaire 25 (VFQ-25) after Neurotidine® vs placebo.
timeFrame: At 6 months compared to baseline
Secondary outcomes:
measure: The change of other scores of the questionnaire: Visual Functioning Questionnaire 25 (VFQ-25).
timeFrame: Up to 9 months compared to baseline
measure: The change of other scores of the questionnaire: Short Form Health Survey - 36 items (SF-36).
timeFrame: Up to 9 months compared to baseline
measure: The safety and tolerability of Neurotidine®.
timeFrame: Up to 9 months compared to baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki
city: Milano
country: Italy
facility: Presidio Ospedale San Paolo
state: MI
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Barcelona
country: Spain
facility: CTIG - Teknon
Study officials:
affiliation: Presidio Ospedale San Paolo
name: Luca Rossetti, Prof.
role: PRINCIPAL_INVESTIGATOR
References: