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

NCT04046809 | Completed

• 2 other identifiers: NEUQOL20182018-002187-11
• Study Type: interventional
• Target: 155
• Locations: 4 countries
• Sites: 5

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®.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• The mean change of "intra-patient" global score of the Visual Functioning Questionnaire 25 (VFQ-25) after Neurotidine® vs placebo.

  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.

  At 6 months compared to baseline

Secondary Outcomes (3)

• The change of other scores of the questionnaire: Visual Functioning Questionnaire 25 (VFQ-25).

  Up to 9 months compared to baseline

• The change of other scores of the questionnaire: Short Form Health Survey - 36 items (SF-36).

  Up to 9 months compared to baseline

• The safety and tolerability of Neurotidine®.

  Up to 9 months compared to baseline

Study Arms (2)

Study Treatment

EXPERIMENTAL

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

Other: Food for special medical purposes: Neurotidine®

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Food for special medical purposes: Neurotidine® 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.

Study Treatment

Placebo 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omikron Italia S.r.l.: lead

Study Sites (5)

University Hospitals Leuven

Leuven, Belgium

Location

Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki

Thessaloniki, Greece

Location

Presidio Ospedale San Paolo

Milan, MI, 20142, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Roma, 00133, Italy

Location

CTIG - Teknon

Barcelona, Spain

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Food

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Luca Rossetti, Prof.

  Presidio Ospedale San Paolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 6, 2019
• Study Start: February 13, 2019
• Primary Completion: December 7, 2021
• Study Completion: January 24, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

BE (1); IT (2); GR (1); ES (1)