Lerner Simon Fabian, Park Ki Ho, Hubatsch Douglas A, Erichev Valeriy, Paczka Jose A, Roberts Timothy V
Organización Medica de Investigación (OMI), Buenos Aires, Argentina; Fundación para el Estudio del Glaucoma, Buenos Aires, Argentina.
Seoul National University Hospital, Seoul, Republic of Korea.
J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23.
. To evaluate the efficacy and tolerability of travoprost 0.004%/timolol 0.5% fixed-dose combination (TTFC) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) inadequately controlled on beta-blocker monotherapy. . In this phase IV, open-label study, 156 patients on beta-blocker monotherapy with mean intraocular pressure (IOP) between 18 and 32 mmHg were randomized (no washout period) to receive TTFC for 8 weeks (TTFC group) or to continue beta-blocker monotherapy for 4 weeks followed by TTFC for the remaining 4 weeks (beta-blocker group). . The mean IOP (±standard deviation) at baseline in the TTFC and beta-blocker groups was 22.5 ± 2.5 mmHg and 22.2 ± 2.3 mmHg, respectively, and at weeks 4 and 8, was 16.7 ± 3.1 mmHg and 16.1 ± 3.1 mmHg, respectively, in TTFC group and 21.1 ± 3.1 mmHg and 16.1 ± 2.8 mmHg, respectively, in the beta-blocker group. There was a significant least squares mean difference between TTFC and beta-blocker in 8 a.m. IOP at week 4 (-4.6 mmHg; one-sided 95% confidence interval [-inf, -3.9]; < 0.0001 [primary endpoint]); the upper bound of the 95% confidence interval was within the prespecified limit (<0). Both treatments were well tolerated. . Superior IOP control was achieved with TTFC in patients with OAG or OHT previously uncontrolled with beta-blockers. No new safety findings were identified. This trial is registered with ClinicalTrials.gov NCT02003391.
评估0.004%曲伏前列素/0.5%噻吗洛尔固定剂量复方制剂（TTFC）用于β受体阻滞剂单药治疗控制不佳的开角型青光眼（OAG）或高眼压症（OHT）患者的疗效和耐受性。在这项IV期开放标签研究中，156例接受β受体阻滞剂单药治疗、平均眼压（IOP）在18至32 mmHg之间的患者被随机分组（无洗脱期），接受TTFC治疗8周（TTFC组），或继续β受体阻滞剂单药治疗4周，然后在剩余4周接受TTFC治疗（β受体阻滞剂组）。TTFC组和β受体阻滞剂组基线时的平均IOP（±标准差）分别为22.5±2.5 mmHg和22.2±2.3 mmHg，在第4周和第8周时，TTFC组分别为16.7±3.1 mmHg和16.1±3.1 mmHg，β受体阻滞剂组分别为21.1±3.1 mmHg和16.1±2.8 mmHg。在第4周上午8点的IOP方面，TTFC组和β受体阻滞剂组之间存在显著的最小二乘均值差异（-4.6 mmHg；单侧95%置信区间[-inf, -3.9]；P<0.0001[主要终点]）；95%置信区间的上限在预先设定的限值内（<0）。两种治疗耐受性均良好。对于先前使用β受体阻滞剂未得到控制的OAG或OHT患者，TTFC实现了更好的IOP控制。未发现新的安全性发现。该试验已在ClinicalTrials.gov注册，注册号为NCT02003391。
