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

• ClinicalTrials.gov Identifier: NCT04046809
• Recruitment Status: Active, not recruiting
• First Posted: August 6, 2019
• Last Update Posted: February 16, 2021
• Sponsor: Omikron Italia S.r.l.
• Information provided by (Responsible Party): Omikron Italia S.r.l.

Study Description

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®.

Condition or disease	Intervention/treatment	Phase
Glaucoma	Other: Food for special medical purposes: Neurotidine®; Other: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Neurotidine® (Citicoline Free Acid in Oral Solution) on Quality of Life in Patients With Glaucoma
• Actual Study Start Date: February 13, 2019
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: October 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study Treatment; 500 ml oral solution containing citicoline free acid 50 mg/ml.	Other: 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.
Placebo Comparator: Placebo; 500 ml oral solution indistinguishable from active product in appearance and taste	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.

Outcome Measures

Primary Outcome Measures :

1. The mean change of "intra-patient" global score of the Visual Functioning Questionnaire 25 (VFQ-25) after Neurotidine® vs placebo. [ Time Frame: At 6 months compared to baseline ]
   Primary outcome is based on the global score of the VFQ-25 questionnaire. Specifically, the VFQ-25 consists of a base set of 25 vision targeted questions. The global score derives from the summary of the scores deriving from each question. The total score has a minimum value "0" considered as the worst visual functionality, and the maximum value "100" considered as the better visual functionality.

Secondary Outcome Measures :

1. The change of other scores of the questionnaire: Visual Functioning Questionnaire 25 (VFQ-25). [ Time Frame: Up to 9 months compared to baseline ]
   Other score utilized in the study: general health, general vision, near and far activities, social, mental, role difficulties, etc.
2. The change of other scores of the questionnaire: Short Form Health Survey - 36 items (SF-36). [ Time Frame: Up to 9 months compared to baseline ]
   Other score utilized in the study: general health, general vision, near and far activities, social, mental, role difficulties, etc.
3. The safety and tolerability of Neurotidine®. [ Time Frame: Up to 9 months compared to baseline ]
   The safety and tolerability of Neurotidine® will be detected on the basis of possible adverse events. In particular, they will be documented in the CRF. Possible adverse events will be communicated directly by the patient and/or detected by the Investigator during the medical examination.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Belgium

University Hospitals Leuven

Leuven, Belgium

Greece

Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki

Thessaloniki, Greece

Italy

Presidio Ospedale San Paolo

Milano, MI, Italy, 20142

Fondazione PTV Policlinico Tor Vergata

Roma, Italy, 00133

Spain

CTIG - Teknon

Barcelona, Spain

Sponsors and Collaborators

Omikron Italia S.r.l.

Investigators

• Principal Investigator: Luca Rossetti, Prof.; Presidio Ospedale San Paolo

  Study Documents (Full-Text)

Documents provided by Omikron Italia S.r.l.:

Study Protocol and Statistical Analysis Plan  [PDF] June 28, 2018

More Information

• Responsible Party: Omikron Italia S.r.l.
• ClinicalTrials.gov Identifier: NCT04046809
• Other Study ID Numbers: NEUQOL2018; 2018-002187-11 ( EudraCT Number )
• First Posted: August 6, 2019
• Last Update Posted: February 16, 2021
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases