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Introduction: A non-interventional, multicenter, European, prospective evaluation of the effectiveness, tolerability, and safety of a topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) demonstrating insufficient response to topical beta-receptor blockers or prostaglandin analogue (PGA) monotherapy. Methods: Mean intraocular pressure (IOP) change from baseline was measured at study visits following a switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change at month 6. Change from baseline concerning ocular signs and symptoms was also explored.Results: Analyses included 577 patients (59.6% female). Mean age (SD) was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p \ 0.0001 for all visits). At month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on C 20%, C 25%, C 30%, and C 35% cutoff values for mean IOP, respectively. Significant reductions were observed concerning corneal fluorescein staining (p \ 0.0001), dry eye symptoms, irritation, itching, and foreign body sensation (p \ 0.001 for each parameter). Conjunctival hyperemia was significantly reduced at all study visits (p \ 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) were reported, one of which was serious (status asthmaticus). Most AEs were mild to moderate in severity, and the majority had resolved or were resolving at the end of the study period. Conclusion: In clinical practice, PF tafluprost/timolol FC provided statistically and clinically significant IOP reductions in patients with OAG and OHT insufficiently controlled on or intolerant to PGA or beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and was maintained over the 6-month study period. Key symptoms of ocular surface health improved. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.The members of The VISIONARY Study Group are listed in Acknowledgements. Key Summary PointsWhy carry out this study?Prostaglandin analogue (PGA) and betareceptor blocker combination therapies are among the most extensively used intraocular pressure (IOP)-lowering treatments in glaucoma care. Fixed-dose combinations simplify the treatment regimen and reduce the number of daily instillations, compared with administration of the corresponding concomitant medications, and preservative-free formulations are generally considered to offer improved tolerability.The VISIONARY study aimed to provide real-world data concerning the treatment effectiveness of the preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in people with open-angle glaucoma (OAG) and ocular hypertension (OHT) who demonstrated an insufficient response ...

Our results suggest that the current CLS technique cannot be clinically used to monitor IOP decrease induced by topical medication in glaucoma, and has limited value in identification of transient IOP elevation periods.

In this white screening population with relatively high risk for mild glaucomatous damage, a combination of different GDx-VCC criteria was useful for glaucoma screening; but combinations of HRT criteria or combinations of GDx-VCC criteria with HRT criteria were less good for this purpose.

The accuracy of referrals was poor in the UK and the other countries. Requiring a combination of criteria and raising the IOP threshold for IOP-only referrals are needed to cut waste in clinical care.