Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04020705
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2019-04-12
Brief Title:
The Efficacy of Citicoline in Eyedrops OMK1 in Reducing the Progression of Glaucoma
Sponsor:
Istituto di Ricerca Neuroftalmologia Srl
Organization:
Istituto di Ricerca Neuroftalmologia Srl
Study Overview
Official Title:
The Efficacy of Citicoline in Eyedrops OMK1 in Reducing the Progression of Glaucoma
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Double-blind study OMK1 vs Placebo A total of 90 patients 30 per center will be the study sample The study will include patients with Primary Open angle Glaucoma glaucoma or pseudoexfoliation with a loss of visual field with MD between -2 dB and -15 decibel
Patients will be randomized into 2 treatment groups both treated with hypotonic ocular drug therapy one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years the remaining part will receive a placebo
All patients will be followed with quarterly visits which will check in addition to the intraocular pressure IOP the structure of the optic nerve and visual function standard visual field
The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry SAP
The secondary objective is to assess the tolerability and safety of OMK1 eye drops
Patients will be randomized into 2 treatment groups both treated with hypotonic ocular drug therapy one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years the remaining part will receive a placebo
All patients will be followed with quarterly visits which will check in addition to the intraocular pressure IOP the structure of the optic nerve and visual function standard visual field
The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry SAP
The secondary objective is to assess the tolerability and safety of OMK1 eye drops
Detailed Description:
None
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