GlaucomaNCT04046809
Study of Neurotidine® Intake on Life Quality of Patients With Glaucoma
A study testing Food for special medical purposes: Neurotidine® in people with Glaucoma, run by Omikron Italia S.r.l. at 5 sites in 4 countries.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Food for special medical purposes: Neurotidine®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 13 Feb 2019to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Italy2 sites
Presidio Ospedale San Paolo
Milan, MI, 20142
Fondazione PTV Policlinico Tor Vergata
Roma, 00133
Greece1 site
Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki
Thessaloniki
About this study
Official title: Effect of Neurotidine® (Citicoline Free Acid in Oral Solution) on Quality of Life in Patients With Glaucoma
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®.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Food for special medical purposes: Neurotidine®, Placebo
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | 500 ml oral solution containing citicoline free acid 50 mg/ml. Receives: Other: Food for special medical purposes: Neurotidine® |
| Placebo | Placebo comparator | 500 ml oral solution indistinguishable from active product in appearance and taste Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months compared to baseline
Secondary outcomes (3)
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.
Measured: Up to 9 months compared to baseline
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.
Measured: Up to 9 months compared to baseline
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.
Measured: Up to 9 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start13 Feb 2019
- Primary completion7 Dec 2021
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omikron Italia S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca Rossetti, Prof., Principal investigator, Presidio Ospedale San Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046809
- Sponsor's protocol ID
- NEUQOL2018
- Other IDs
- 2018-002187-11, 2018
- Status last verified
- Apr 2022
- First submitted
- 29 Jul 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurotidine® (Citicoline Free Acid in Oral Solution) on Quality of Life in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT04046809
- Acronym / sponsor ID
- NEUQOL2018
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Omikron Italia S.r.l.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Experimental | Other: Food for special medical purposes: Neurotidine®500 ml oral solution containing citicoline free acid 50 mg/ml. |
| Placebo | Placebo comparator | Other: Placebo500 ml oral solution indistinguishable from active product in appearance and taste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Study Treatment |
| PlaceboEach 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. | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
The change of other scores of the questionnaire: Visual Functioning Questionnaire 25 (VFQ-25).
Time frame: Up to 9 months compared to baseline
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
The safety and tolerability of Neurotidine®.
Time frame: Up to 9 months compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Rossetti, Prof. principal investigator
Presidio Ospedale San Paolo
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food for special medical purposes: Neurotidine® in people with Glaucoma, run by Omikron Italia S.r.l. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Belgium, Greece, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.