Oddone Francesco, Scorcia Vincenzo, Iester Michele, Sisto Dario, De Cilla Stefano, Bettin Paolo, Cagini Carlo, Figus Michele, Marchini Giorgio, Rossetti Luca, Rossi Gemma, Salgarello Tommaso, Scuderi Gian Luca, Staurenghi Giovanni
Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy.
Department of Ophthalmology, University Magna Græcia of Catanzaro, Catanzaro, Italy.
Clin Ophthalmol. 2022 Jun 1;16:1707-1719. doi: 10.2147/OPTH.S364880. eCollection 2022.
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.
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 beta-blocker 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).
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). .
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.
VISIONARY研究在实际临床环境中，考察了不含防腐剂的他氟前列素（0.0015%）与噻吗洛尔（0.5%）固定剂量组合（PF他氟前列素/噻吗洛尔复方制剂）降低眼压（IOP）的疗效及耐受性。本文所报告的国家级数据，是意大利针对PF他氟前列素/噻吗洛尔复方制剂治疗开展的规模最大的首次观察性研究。
一项观察性、多中心、前瞻性研究纳入了患有开角型青光眼（OAG）或高眼压症（OHT）的成年意大利患者，这些患者对局部使用前列腺素类似物（PGA）或β受体阻滞剂单药治疗反应不足或耐受性差。在基线时将治疗转换为PF他氟前列素/噻吗洛尔复方制剂治疗。主要终点是第6个月时相对于基线的绝对平均眼压变化。探索性终点和安全性终点包括第4周和第12周时眼压的变化、眼部体征、症状严重程度以及不良事件（AE）报告。
总共纳入了160例OAG/OHT患者。平均眼压从基线时的19.6±3.6 mmHg降至第6个月时的14.5±2.6 mmHg（降低了5.1±3.7 mmHg；24.1%；p<0.0001）。在第4周（23.1%；p<0.0001）和第12周（24.7%；p<0.0001）时，眼压降低也具有统计学意义。根据平均眼压变化≥20%、≥25%、≥30%和≥35%的数据截止值，第6个月时的缓解率分别为68.1%、48.
