Effectiveness and Safety of Switching to Fixed-Dose, Preservative-Free Tafluprost/Timolol in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: A Real-World Study in Taiwan.

Objective The objective of this study is to evaluate the effectiveness, safety, and tolerability of a preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methodology This real-world, prospective, noninterventional study was conducted in Taiwanese patients with OAG or OHT who had an inadequate response or intolerance to topical prostaglandin analogue (PGA) monotherapy and were therefore switched to PF tafluprost/timolol FC. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to six months after initiating treatment. Changes in clinical signs and subjective symptoms were also evaluated, and adverse events (AEs) were recorded. Results A total of 49 patients were enrolled, and 42 completed the study. The mean ± SD IOP at baseline was 16.5 ± 3.5 mmHg, which significantly decreased to 15.4 ± 3.4 mmHg at six months (absolute reduction: 1.1 ± 2.6 mmHg; p < 0.001). The number of patients with a tear break-up time >10 seconds increased significantly from three (7.5%) at baseline to 22 (52.5%) at six months (p < 0.001). However, a nonsignificant increase was observed in subjective symptoms. Six treatment-related AEs were reported, all of which were nonserious and mild to moderate in severity, including contact dermatitis, redness and itchiness, and blurred vision. Conclusions This real-world, prospective study in Taiwan demonstrated that switching patients with OAG or OHT from PGA monotherapy to PF tafluprost/timolol FC was effective and safe for reducing IOP.