Can Treatment with Citicoline Eyedrops Reduce Progression in Glaucoma? The Results of a Randomized Placebo-controlled Clinical Trial

Precis: Citicoline eyedrops in patients with progressing glaucoma. Purpose: To test whether the additional therapy with citicoline eyedrops to intraocular pressure (IOP)-lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mmHg or less. Design: Randomized, double-masked, placebo-controlled, multicenter 3-year study. Outcomes: Difference in visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression; difference in retinal nerve fiber layer (RNFL) thickness change between the 2 study groups at 3 years. Methods: Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least-0.5▒dB/y in the 2 years before enrolment despite IOP ≤18▒mmHg, were randomized to receive citicoline eyedrops or placebo 3 times daily for 3 years. Patients were followed every 3 months and underwent visual field examination with 24-2 and 10-2 strategies and RNFL assessment. ANOVA and linear models were used to test the differences between groups. Results: Eighty patients were randomized in the trial. Mean three-year rates of progression were-1.03 (2.14) dB in citicoline group and-1.92 (2.23) dB in the placebo group (P=0.07) for 24-2 MD and-0.41 (3.45) dB in citicoline group and-2.22 (3.63) dB in the placebo group (P=0.02) for 10-2 MD. On average patients receiving citicoline eyedrops lost 1.86 microns of RNFL in 3 years, versus 2.99 microns in the placebo group (P=0.02). Conclusions: Additional treatment with citicoline eyedrops to IOP-lowering treatment might reduce disease progression in patients with progressing glaucoma despite IOP ≤18▒mmHg.