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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Food for special medical purposes: Neurotidine®
Placebo
Sponsored by
Omikron Italia S.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospitals Leuven
  • Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki
  • Presidio Ospedale San Paolo
  • Fondazione PTV Policlinico Tor Vergata
  • CTIG - Teknon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Treatment

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The change of other scores of the questionnaire: Visual Functioning Questionnaire 25 (VFQ-25).
Other score utilized in the study: general health, general vision, near and far activities, social, mental, role difficulties, etc.
The change of other scores of the questionnaire: Short Form Health Survey - 36 items (SF-36).
Other score utilized in the study: general health, general vision, near and far activities, social, mental, role difficulties, etc.
The safety and tolerability of Neurotidine®.
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.

Full Information

First Posted
July 29, 2019
Last Updated
April 28, 2022
Sponsor
Omikron Italia S.r.l.
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1. Study Identification

Unique Protocol Identification Number
NCT04046809
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
January 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omikron Italia S.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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®.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Treatment
Arm Type
Experimental
Arm Description
500 ml oral solution containing citicoline free acid 50 mg/ml.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 ml oral solution indistinguishable from active product in appearance and taste
Intervention Type
Other
Intervention Name(s)
Food for special medical purposes: Neurotidine®
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The mean change of "intra-patient" global score of the Visual Functioning Questionnaire 25 (VFQ-25) after Neurotidine® vs placebo.
Description
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.
Time Frame
At 6 months compared to baseline
Secondary Outcome Measure Information:
Title
The change of other scores of the questionnaire: Visual Functioning Questionnaire 25 (VFQ-25).
Description
Other score utilized in the study: general health, general vision, near and far activities, social, mental, role difficulties, etc.
Time Frame
Up to 9 months compared to baseline
Title
The change of other scores of the questionnaire: Short Form Health Survey - 36 items (SF-36).
Description
Other score utilized in the study: general health, general vision, near and far activities, social, mental, role difficulties, etc.
Time Frame
Up to 9 months compared to baseline
Title
The safety and tolerability of Neurotidine®.
Description
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.
Time Frame
Up to 9 months compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Rossetti, Prof.
Organizational Affiliation
Presidio Ospedale San Paolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Name
Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
Presidio Ospedale San Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
CTIG - Teknon
City
Barcelona
Country
Spain

12. IPD Sharing Statement

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

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