NCT04003090

Citicoline Concentration in Human Vitreous

Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration: a Cross-sectional Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Istituto di Ricerca Neuroftalmologia S.r.l. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Elegible patients were included in the study and underwent treatment with a solution of citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride prior to surgery. The vitreous samples were taken at the beginning of the surgery and analyzed for qualitative/quantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography.

Detailed description

At the visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, IOP measurement using Goldmann applanation tonometry, and fundus dilated indirect ophthalmoscopy. Additionally, all patients had central retinal thickness measurements with spectral-domain optical coherence tomography associated with central corneal thickness (CCT) and corneal endothelial cells density (ECD) evaluations. Patients started the treatment with 1 drop of a solution of citicoline 1% eye-drops, 0.2% hyaluronic acid and 0.01% benzalkonium chloride for 3 times/day over a total time of 14 days before surgery and 1 drop 2 hours prior to the surgery. Five patients served as controls and received a vehicle solution without citicoline. The primary aim of the study was to evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration by means of high performance liquid chromatography. Secondary aims were the comparison of citicoline and its metabolites concentration in the vitreous of treated phakic and pseudophakic eyes and the correlations with age and ocular biometric parameters including CCT and ECD.

Conditions

• Neurodegenerative Diseases

Interventions

Type	Name	Description
DRUG	Citicoline	After treatment with a solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride patients underwent a 23G standard 3-port pars plana vitrectomy. The vitreous sample was taken at the beginning of the surgery and then analyzed.

Timeline

• Start date: 2018-03-21
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2019-07-01
• Last updated: 2019-07-01

Locations

1 site across 1 country: Italy