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

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.