Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma

Not Applicable

Not yet recruiting

• Conditions: Glaucoma

• Registration Number: NCT06333236
• Lead Sponsor: ASST Santi Paolo e Carlo

Brief Summary

Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml 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 40mg/ml and nicotinamide 15mg/ml) 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 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day)

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study Start: 2024-03-25
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• glaucomatous patients with moderate visual field loss, MD ranging from -6 dB and -12 dB, and risk of progression
• controlled intraocular pressure
• at least 3 previous visual field examinations.

Exclusion Criteria

• angle closure glaucoma and secondary open angle glaucoma
• refractive error outside +2D and -6D
• ophthalmic surgery 6 months before the recruitment
• presence of cataract or other conditions that could affect results of perimetry or electroretinography
• treatment with supplements in any form with a demonstrated or presumed neuroprotecting/neuroenhancing effect in the last six months
• presence of other ocular or systemic diseases that could affect results of perimetry or electroretinography.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Electrofunctional evaluation	3 months	Short term improvement in inner retinal function and bioelectrical activity of the visual cortex evaluated by means of PERG (P50 and N95 peaks) and PEV (P100 implicit time and N75-P100 amplitude) pattern.

Secondary Outcome Measures

Name	Time	Method
VF and SD-OCT	3 months	Visual field examination will be performed at the beginning and at the end of trial. Standard pattern short-term improvement in visual function in treated patients evaluated by means of VF. Retinal nerve fiber layer thickness, ganglion cell complex thickness and minimum rim width will be evaluated at the baseline and at the end of the study.