Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333236
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-01
Brief Title:
Effect of Kron Citicoline and Nicotinamide Oral Solution on Patients With Open-angle Glaucoma
Sponsor:
ASST Santi Paolo e Carlo
Organization:
ASST Santi Paolo e Carlo
Study Overview
Official Title:
Effect of Kron Citicoline and Nicotinamide Oral Solution on Patients With Open-angle Glaucoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
Aim of this study is to investigate the administration effects of the combination of citicoline 40mgml and nicotinamide 15mgml oral solution Kron on short term improvement in inner retinal function bioelectrical activity of the visual cortex and visual function
Detailed Description:
Prospective masked randomized placebo-controlled study to evalute the offect of the oral solution Kron citicoline 40mgml and nicotinamide 15mgml on patients with a diagnosis of open angle glaucoma and risk of glaucoma progression
Glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms
1 Treatment group TG 20 patients will receive Citicoline 40 mgml Nicotinamide 15 mgml oral solution for 3 months 10 mlday
2 Control group CG 10 patients will be evaluated as control
Once recruited a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline week 6 and week 12 The following examinations will be done in the following sequence
Visual acuity
Slit lamp evaluation
PERG
PEV pattern
Tonometry
Visual field
Optical Coherence Tomography
Dilated Fundus examination
Glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms
1 Treatment group TG 20 patients will receive Citicoline 40 mgml Nicotinamide 15 mgml oral solution for 3 months 10 mlday
2 Control group CG 10 patients will be evaluated as control
Once recruited a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline week 6 and week 12 The following examinations will be done in the following sequence
Visual acuity
Slit lamp evaluation
PERG
PEV pattern
Tonometry
Visual field
Optical Coherence Tomography
Dilated Fundus examination
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