Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05710198
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-01-24
Brief Title:
Efficacy of Citicoline Eye Drops 2 on Visual Field Preservation in Patients With Open Angle Glaucoma
Sponsor:
Omikron Italia Srl
Organization:
Omikron Italia Srl
Study Overview
Official Title:
A Phase III Multicenter Double-blind Randomized Placebo-controlled Parallel-group Trial of the Efficacy of Citicoline Eye Drops 2 on Visual Field Preservation in Patients With Open Angle Glaucoma
Status:
RECRUITING
Status Verified Date:
2024-03
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:
To evaluate the efficacy of citicoline eye drops 2 in reducing visual field deterioration in patients with progressing OAG treated according to best clinical practice Secondary objectives are assessing the effect of citicoline eye drops 2 on changes in structural parameters measured by Spectral Domain Optical Coherence Tomography SD-OCT and evaluating the safety of citicoline eye drops 2
Detailed Description:
Background Primary open angle glaucoma OAG is a chronic progressive neurodegenerative disease where intraocular pressure IOP is the main and successfully treatable risk factor Although the treatment effect is quite large a significant proportion of patients show disease progression with apparently well controlled IOP Given the similarities with other neurodegenerative diseases - particularly in the mechanisms of cell death - neuroprotective treatments have been tested also in glaucoma Interesting results from experimental studies and first 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 evaluated in patients with various neurodegenerative diseases with encouraging results The mechanism of action of citicoline is multifarious and includes preservation of cardiolipin and sphingomyelin restoration of phosphatidylcholine stimulation of glutathione synthesis lowering of glutamate concentration rescuing mitochondrial function and others Pilot studies on glaucomatous patients showed a possible effect of citicoline as additive therapy in the treatment of glaucoma in reducing progression of visual field changes in protecting retinal nerve fiber layers and in improving vision related Quality of Life QoL though these findings are yet to be confirmed by a large randomized clinical trial
Citicoline is one of the promising molecules with a putative neuroprotective action and has been evaluated in patients with various neurodegenerative diseases with encouraging results The mechanism of action of citicoline is multifarious and includes preservation of cardiolipin and sphingomyelin restoration of phosphatidylcholine stimulation of glutathione synthesis lowering of glutamate concentration rescuing mitochondrial function and others Pilot studies on glaucomatous patients showed a possible effect of citicoline as additive therapy in the treatment of glaucoma in reducing progression of visual field changes in protecting retinal nerve fiber layers and in improving vision related Quality of Life QoL though these findings are yet to be confirmed by a large randomized clinical trial
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