拉坦前列素苯丁诺啡 0.024%与马来酸噻吗洛尔 0.5%在开角型青光眼或高眼压症受试者中的比较：APOLLO 研究。
Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study.
机构信息
Hamilton Glaucoma Center, Shiley Eye Institute and Department of Ophthalmology, University of California San Diego, La Jolla, California.
Bausch & Lomb, Bridgewater, New Jersey.
出版信息
Ophthalmology. 2016 May;123(5):965-73. doi: 10.1016/j.ophtha.2016.01.019. Epub 2016 Feb 11.
PURPOSE
To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) ophthalmic solution 0.024% every evening (qpm) with timolol maleate 0.5% twice daily (BID) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
DESIGN
Phase 3, randomized, controlled, multicenter, double-masked, parallel-group clinical study.
PARTICIPANTS
Subjects aged ≥18 years with a diagnosis of OAG or OHT in 1 or both eyes.
METHODS
Subjects were randomized (2:1) to a 3-month regimen of LBN 0.024% qpm or timolol 0.5% 1 drop BID. Intraocular pressure was measured at 8 am, 12 pm, and 4 pm of each postrandomization visit (week 2, week 6, and month 3). Adverse events were recorded throughout the study.
MAIN OUTCOME MEASURES
The primary efficacy end point was IOP in the study eye measured at each of the 9 assessment time points. Secondary efficacy end points included the proportion of subjects with IOP ≤18 mmHg consistently at all 9 time points and the proportion of subjects with IOP reduction ≥25% consistently at all 9 time points.
RESULTS
Of 420 subjects randomized, 387 completed the study (LBN 0.024%, n = 264; timolol 0.5%, n = 123). At all 9 time points, the mean IOP in the study eye was significantly lower in the LBN 0.024% group than in the timolol 0.5% group (P ≤ 0.002). At all 9 time points, the percentage of subjects with mean IOP ≤18 mmHg and the percentage with IOP reduction ≥25% were significantly higher in the LBN 0.024% group versus the timolol 0.5% group (mean IOP ≤18 mmHg: 22.9% vs. 11.3%, P = 0.005; IOP reduction ≥25%: 34.9% vs. 19.5%, P = 0.001). Adverse events were similar in both treatment groups.
CONCLUSIONS
In this phase 3 study, LBN 0.024% qpm demonstrated significantly greater IOP lowering than timolol 0.5% BID throughout the day over 3 months of treatment. Latanoprostene bunod 0.024% was effective and safe in these adults with OAG or OHT.
目的
比较每晚（qpm）使用拉坦前列素丁基眼用溶液 0.024%和每日两次（BID）使用马来酸噻吗洛尔 0.5%治疗开角型青光眼（OAG）或高眼压症（OHT）患者的日间眼压（IOP）降低效果。
设计
3 期、随机、对照、多中心、双盲、平行组临床研究。
参与者
年龄≥18 岁的单眼或双眼诊断为 OAG 或 OHT 的患者。
方法
受试者随机（2:1）接受为期 3 个月的治疗方案，分别为每晚（qpm）使用拉坦前列素丁基眼用溶液 0.024%或每日两次（BID）使用马来酸噻吗洛尔 0.5%。在每个随机后访视（第 2 周、第 6 周和第 3 个月）的 8 点、12 点和 4 点测量眼内压。整个研究期间记录不良事件。
主要疗效终点
研究眼的眼压是主要疗效终点，在 9 个评估时间点的每个时间点进行测量。次要疗效终点包括在所有 9 个时间点始终有≤18mmHg 的眼压的受试者比例和在所有 9 个时间点始终有 IOP 降低≥25%的受试者比例。
结果
在 420 名随机患者中，387 名完成了研究（拉坦前列素丁基眼用溶液 0.024%组，n=264；马来酸噻吗洛尔 0.5%组，n=123）。在所有 9 个时间点，研究眼中的平均 IOP 均显著低于拉坦前列素丁基眼用溶液 0.024%组（P≤0.002）。在所有 9 个时间点，拉坦前列素丁基眼用溶液 0.024%组的平均 IOP≤18mmHg 和 IOP 降低≥25%的受试者比例显著高于马来酸噻吗洛尔 0.5%组（平均 IOP≤18mmHg：22.9% vs. 11.3%，P=0.005；IOP 降低≥25%：34.9% vs. 19.5%，P=0.001）。两组的不良事件相似。
结论
在这项 3 期研究中，拉坦前列素丁基眼用溶液 0.024% qpm 在 3 个月的治疗期间，与马来酸噻吗洛尔 0.5% BID 相比，全天显著降低了眼压。在这些患有 OAG 或 OHT 的成年人中，拉坦前列素丁基眼用溶液 0.024%是有效且安全的。
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