The effect of citicoline oral solution on quality of life in patients with glaucoma: the results of an international, multicenter, randomized, placebo-controlled cross-over trial

Luca Rossetti ¹, Francisco Goni ², Giovanni Montesano ³, Ingeborg Stalmans ⁴, Fotis Topouzis ⁵, Dario Romano ⁶, Eleonora Galantin ⁶, Noemi Delgado-Gonzales ², Sara Giammaria ⁷, Giulia Coco ⁸, Evelien Vandewalle ⁴, Sophie Lemmens ⁴, Dimitrios Giannoulis ⁵, Theofanis Pappas ⁵, Gianluca Manni ⁸

Affiliations

• ¹Eye Clinic, ASST Santi Paolo E Carlo, University of Milan, Via Di Rudinì, 8 20142, Milan, Italy. luca.rossetti@unimi.it.
• ²CTIG-Teknon, Barcelona, Spain.
• ³NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
• ⁴University Hospitals Leuven, Louvain, Belgium.
• ⁵Department of Ophthalmology, School of Medicine, Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki, Greece.
• ⁶Eye Clinic, ASST Santi Paolo E Carlo, University of Milan, Via Di Rudinì, 8 20142, Milan, Italy.
• ⁷IRCCS - Fondazione Bietti, Rome, Italy.

⁸Eye Clinic, Policlinico Tor Vergata, Dipartimento Scienze Cliniche e Medicina Traslazionale Rome, Rome, Italy.

Abstract

Purpose: This study aims to evaluate whether the use of citicoline oral solution could improve quality of life in patients with chronic open-angle glaucoma (OAG).

Design: Randomized, double-masked, placebo-controlled, cross-over study was used. Patients were randomized to one of the two sequences: either citicoline 500 mg/day oral solution-placebo or placebo-citicoline 500 mg/day oral solution. Switch of treatments was done after 3 months; patients were then followed for other 6 months. Follow-up included 3-month, 6-month, and 9-month visits.

Outcomes: The primary outcome was the mean change of "intra-patient" composite score of the Visual Function Questionnaire-25 (VFQ-25)^. after citicoline oral solution vs placebo at 6-month visit as compared with baseline.

Methods: The trial was multicenter, conducted at 5 European Eye Clinics. OAG patients with bilateral visual field damage, a mean deviation (MD) ranging from - 5 to - 13 dB in the better eye, and controlled IOP were included. VFQ-25 and SF-36 questionnaires were administered at baseline and at 3-, 6-, and 9-month visits. A mixed effect model, with a random effect on the intercept, accounted for correlations among serial measurements on each subject.

Results: The primary pre-specified outcome of the analysis reached statistical significance (p = 0.0413), showing greater improvement after citicoline oral solution. There was an increase in the composite score in both arms compared to baseline, but it was significant only for the placebo-citicoline arm (p = 0.0096, p = 0.0007, and p = 0.0006 for the three time-points compared to baseline). The effect of citicoline was stronger in patients with vision-related quality of life more affected by glaucoma at baseline.

Conclusions: This is the first placebo-controlled clinical study evaluating the effect of a medical treatment aiming at improving vision-related quality of life in glaucomatous patients.

 

Rossetti, L., Goni, F., Montesano, G., Stalmans, I., Topouzis, F., Romano, D., Galantin, E., Delgado-Gonzales, N., Giammaria, S., Coco, G., Vandewalle, E., Lemmens, S., Giannoulis, D., Pappas, T., & Manni, G. (2023). The effect of citicoline oral solution on quality of life in patients with glaucoma: the results of an international, multicenter, randomized, placebo-controlled cross-over trial. Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 261(6), 1659–1668. https://doi.org/10.1007/s00417-022-05947-5

 

https://pubmed.ncbi.nlm.nih.gov/36639525/

 

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