Ignite Creation Date:
2024-05-06 @ 1:30 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04046809
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2019-07-29
Brief Title:
Study of Neurotidine Intake on Life Quality of Patients With Glaucoma
Sponsor:
Omikron Italia Srl
Organization:
Omikron Italia Srl
Study Overview
Official Title:
Effect of Neurotidine Citicoline Free Acid in Oral Solution on Quality of Life in Patients With Glaucoma
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002187-11 | EUDRACT_NUMBER | None | None |