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

ASST Santi Paolo e Carlo30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glaucoma

Interventions

Food for Special Medical Purposes: Kron®OTHER

Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

ASST Santi Paolo e Carlo

Milan, Mi, Italy

Luca Rossetti

Milan, MI, Italy

Outcomes

Primary Outcomes

Electrofunctional evaluation

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.

Time frame: 3 months

Secondary Outcomes

VF and SD-OCT

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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