Rhee Douglas J, Peace James H, Mallick Sushanta, Landry Theresa A, Bergamini Michael V W
Massachusetts Eye and Ear Infirmary, 243 Charles St., Harvard University, Boston, MA, USA.
Clin Ophthalmol. 2008 Jun;2(2):313-9. doi: 10.2147/opth.s2830.
BACKGROUND/AIMS: To compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% in fixed combination with the unfixed combination of latanoprost 0.005% and timolol 0.5% in open-angle glaucoma or ocular hypertension patients with IOP levels below 18 mmHg on the unfixed combination of latanoprost 0.005% and timolol 0.5%.
Following a 30-day open-label run-in with latanoprost QD PM and timolol QD AM, subjects with intraocular pressure below 18 mmHg were randomized to continue concomitant latanoprost QD PM and timolol QD AM or switch to travoprost 0.004%/timolol 0.5% QD AM and vehicle QD PM in masked fashion and were followed for 3 months. The primary efficacy endpoint was mean IOP reduction from baseline.
There were no clinically relevant or statistically significant differences in mean IOP, mean IOP change from baseline, or percentage IOP change from baseline between the two treatment groups. Between-group differences in mean IOP were within +/-0.3 mmHg at all time points (p >/= 0.384), and between-group differences in mean IOP change from baseline were within +/-0.4 mmHg at all time points. Overall, 88% of patients whose IOP was less than 18 mmHg on the unfixed combination of latanoprost and timolol remained well controlled on the same regimen in the masked portion of the study, compared with 92% who remained well controlled after switching to travoprost/timolol.
Travoprost 0.004%/timolol 0.5% administered once daily and concomitant administration of timolol 0.5% and latanoprost 0.005% produce similar maintenance of IOP-lowering effect in patients who were previously well controlled on concomitant administration of latanoprost and timolol. Patients who are well controlled on latanoprost and timolol concomitant therapy can be switched to once-daily therapy with travoprost 0.004%/timolol 0.5% with no expected compromise in the safety and efficacy of their treatment.
背景/目的：比较0.004%曲伏前列素/0.5%噻吗洛尔固定复方制剂与0.005%拉坦前列素和0.5%噻吗洛尔非固定复方制剂降低开角型青光眼或眼压高患者眼压的疗效，这些患者使用0.005%拉坦前列素和0.5%噻吗洛尔非固定复方制剂时眼压水平低于18 mmHg。
在使用拉坦前列素每日一次晚上给药和噻吗洛尔每日一次早上给药进行30天开放标签导入期后，眼压低于18 mmHg的受试者被随机分组，以盲法继续同时使用拉坦前列素每日一次晚上给药和噻吗洛尔每日一次早上给药，或换用0.004%曲伏前列素/0.5%噻吗洛尔每日一次早上给药和赋形剂每日一次晚上给药，并随访3个月。主要疗效终点是平均眼压较基线的降低幅度。
两个治疗组在平均眼压、平均眼压较基线的变化或平均眼压较基线的变化百分比方面，均无临床相关或统计学上的显著差异。两组间平均眼压的差异在所有时间点均在±0.3 mmHg以内（p≥0.384），两组间平均眼压较基线变化的差异在所有时间点均在±0.4 mmHg以内。总体而言，在研究的盲法阶段，88%使用拉坦前列素和噻吗洛尔非固定复方制剂时眼压低于18 mmHg的患者在相同治疗方案下仍得到良好控制，而换用曲伏前列素/噻吗洛尔后仍得到良好控制的患者为92%。
对于之前使用拉坦前列素和噻吗洛尔联合治疗时病情得到良好控制的患者，每日一次给予0.004%曲伏前列素/0.5%噻吗洛尔以及同时给予0.5%噻吗洛尔和0.005%拉坦前列素，在降低眼压效果的维持方面相似。在拉坦前列素和噻吗洛尔联合治疗中病情得到良好控制的患者，可以换用每日一次的0.004%曲伏前列素/0.5%噻吗洛尔治疗，预计其治疗的安全性和疗效不会受到影响。
