Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients

Abstract

<b>Background</b>: Ideal dosing for the preservative-free (PF) tafluprost/timolol fixed combination (TTFC) remains to be elucidated. <b>Research design and methods</b>: This study was a prospective, observer-masked, placebo-controlled, crossover, comparison in 42 consecutive open-angle glaucoma patients whose intraocular pressure (IOP) was insufficiently controlled with preserved latanoprost monotherapy (mean 24-h IOP >20 mmHg). Patients were randomized to either morning (08:00) or evening (20:00) PF TTFC for 3 months and then crossed over. After each treatment period, patients underwent habitual 24-h IOP monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00, and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00). <b>Results</b>: Mean 24-h IOP on latanoprost was 22.2±3.9 mmHg. Both PF TTFC dosing regimens obtained greater reduction in mean 24-h, daytime, nighttime, and peak 24-h IOP (<i>P</i> < 0.001). Evening dosing provided tighter 24-h IOP fluctuation versus latanoprost (<i>P</i> < 0.001). Evening dosing was superior to morning dosing at four time points (<i>P</i> < 0.01), for the mean daytime IOP (<i>P</i> < 0.001) and mean 24-h IOP fluctuation (<i>P</i> < 0.001). Hyperemia was more common with preserved latanoprost (21.4 vs. 7.1%; <i>P</i> = 0.031). Patients (<i>n</i> = 19; 45%) preferred evening dosing. <b>Conclusions</b>: PF TTFC provided greater 24-h IOP control and less hyperemia compared with preserved latanoprost. Evening administration of this novel medication offered superior 24-h efficacy. <b>Trial registration</b>: Clinicaltrials.gov (NCT03612817).