Treatment of Open-Angle Glaucoma and Ocular Hypertension with the Fixed-Dose Combination of Preservative-Free Tafluprost/Timolol: Clinical Outcomes from Ophthalmology Clinics in Italy

被引：2

作者：

Oddone, Francesco ^{[1
]}

Scorcia, Vincenzo ^{[2
]}

Iester, Michele ^{[3
]}

Sisto, Dario ^{[4
]}

De Cilla, Stefano ^{[5
]}

Bettin, Paolo ^{[6
]}

Cagini, Carlo ^{[7
]}

Figus, Michele ^{[8
]}

Marchini, Giorgio ^{[9
]}

Rossetti, Luca ^{[10
]}

Rossi, Gemma ^{[11
]}

Salgarello, Tommaso ^{[12
,13
]}

Scuderi, Gian Luca ^{[14
]}

Staurenghi, Giovanni ^{[15
]}

机构：

[1] IRCSS Fdn Bietti, Glaucoma Unit, Rome, Italy

[2] Magna Graecia Univ Catanzaro, Dept Ophthalmol, Catanzaro, Italy

[3] Univ Genoa, Eye Clin Genoa, Dept Neurosci Rehabil Ophthalmol Genet Maternal &, Genoa, Italy

[4] Univ Bari, Dept Ophthalmol, Bari, Italy

[5] Univ Piemonte Orientale, Dept Hlth Sci, Eye Clin, Novara, Italy

[6] Univ Vita Salute San Raffaele, Dept Ophthalmol, IRCCS San Raffaele Sci Inst, Milan, Italy

[7] Univ Perugia, Ophthalmol Sect, Dept Med & Surg, Perugia, Italy

[8] Univ Pisa, Dept Surg Med Mol & Emergency, Ophthalmol, Pisa, Italy

[9] Univ Verona, Dept Neurosci Biomed & Movement, Ophthalmol Unit, Verona, Italy

[10] Univ Milan, San Paolo Hosp, Eye Clin, Milan, Italy

[11] Fdn IRCCS Policlin S Matteo, Univ Eye Clin, Pavia, Italy

[12] Fdn Policlin Univ A Gemelli IRCCS, Ophthalmol Unit, Dept Ageing Neurosci Head Neck & Orthopaed Sci, Pavia, Italy

[13] Univ Cattolica Sacro Cuore, Inst Ophthalmol, Rome, Italy

[14] Univ Roma La Sapienza, St Andrea Hosp, NESMOS Dept, Ophthalmol Unit, Rome, Italy

[15] Univ Milan, Dept Biomed & Clin Sci Luigi Sacco, Eye Clin, Milan, Italy

来源：

CLINICAL OPHTHALMOLOGY | 2022年 / 16卷

关键词：

fixed-dose combination therapy; intraocular pressure; ocular hypertension; PF tafluprost; timolol FC; preservative-free topical medication; primary open-angle glaucoma; FREE PROSTAGLANDIN ANALOGS; INTRAOCULAR-PRESSURE; SURFACE DISEASE; TIMOLOL; 0.5-PERCENT; DRY EYE; EFFICACY; SAFETY; TOLERABILITY; PREVALENCE; 0.0015-PERCENT;

D O I：

10.2147/OPTH.S364880

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

Introduction: The VISIONARY study examined the intraocular pressure (IOP)-lowering efficacy and tolerability of the preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in a real-world setting. The country-level data reported herein comprise the largest and first observational study of PF tafluprost/timolol FC therapy in Italy. Methods: An observational, multicenter, prospective study included adult Italian patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) demonstrating insufficient response or poor tolerability with topical prostaglandin analogue (PGA) or betablocker monotherapy. Treatment was switched to PF tafluprost/timolol FC therapy at baseline. Primary endpoint was the absolute mean IOP change from baseline at Month 6. Exploratory and safety endpoints included change in IOP at Weeks 4 and 12, ocular signs, symptom severity and reporting of adverse events (AEs). Results: Overall, 160 OAG/OHT patients were included. Mean +/- standard deviation IOP was reduced from 19.6 +/- 3.6 mmHg at baseline to 14.5 +/- 2.6 mmHg at Month 6 (reduction of 5.1 +/- 3.7 mmHg; 24.1%; p < 0.0001). IOP reduction was also statistically significant at Week 4 (23.1%; p < 0.0001) and Week 12 (24.7%; p < 0.0001). Based on data cutoff values for mean IOP change of >= 20%, >= 25%, >= 30% and >= 35%, respective Month 6 responder rates were 68.1%, 48.7%, 36.2% and 26.9%. Most ocular signs and symptoms were significantly reduced in severity from baseline at Month 6. Two non-serious and mild AEs were reported during the study period, among which, one AE was treatment-related (eyelash growth). Conclusion: Italian OAG and OHT patients demonstrated a significant IOP reduction from baseline at Week 4 that was maintained over a 6-month period following a switch from topical PGA or beta-blocker monotherapy to PF tafluprost/timolol FC therapy. Severity of most ocular signs and symptoms was significantly reduced during the study period, and PF tafluprost/timolol FC was generally well tolerated.

引用

页码：1707 / 1719

页数：13

共 50 条

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