TY - JOUR

T1 - Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy

T2 - The VISIONARY Study

AU - Oddone, Francesco

AU - Tanga, Lucia

AU - Kóthy, Péter

AU - Holló, Gábor

AU - The VISIONARY Study Group

AU - Faschinger, Christoph

AU - Chen, Enping

AU - Holló, Gabor

AU - Nemeth, Gabor

AU - Bator, Gyorgy

AU - Tsorbatzoglou, Alexis

AU - Acs, Tamas

AU - Ferencz, Maria

AU - Sohajda, Zoltán

AU - Toth, Jeno

AU - Volner, Veronika

AU - Vogt, Gabor

AU - Biro, Zsolt

AU - Facskó, Andrea

AU - Nemes, János

AU - Berta, Andras

AU - Elek, Ilona

AU - Ng, Eugene

AU - Oddone, Francesco

AU - Rossi, Gemma

AU - Rossetti, Luca

AU - Vetrugno, Michele

AU - Iester, Michele

AU - Marchini, Giorgio

AU - Scorcia, Vincenzo

AU - Staurenghi, Giovanni

AU - Cagini, Carlo

AU - Salgarello, Tommaso

AU - Bettin, Paolo

AU - Figus, Michele

AU - Scuderi, Gian Luca

AU - De Cilla, Stefano

AU - Grundmane, Iveta

AU - Linavska, Nora

AU - Volksone, Lasma

AU - Laganovska, Guna

AU - Baumane, Kristine

AU - Lemij, Hans

AU - Gundersen, Kjell Gunnar

AU - Zimina, Marina

AU - Erichev, Valery

AU - Karlova, Elena

AU - Zakharova, Ekaterina

AU - Panova, Irina

AU - Malyugin, Boris

AU - Kolko, Miriam

PY - 2020

Y1 - 2020

N2 - 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 ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 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.

AB - 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 ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 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.

KW - Fixed-dose combination

KW - Ocular hypertension

KW - Open-angle glaucoma

KW - Ophthalmology

KW - Preservative-free topical medication

KW - Tafluprost

KW - Timolol

U2 - 10.1007/s12325-020-01239-8

DO - 10.1007/s12325-020-01239-8

M3 - Journal article

C2 - 32072493

AN - SCOPUS:85079762426

VL - 37

SP - 1436

EP - 1451

JO - Advances in Therapy

JF - Advances in Therapy

SN - 0741-238X

ER -