Bacharach Jason, Ahmed Iqbal Ike K, Sharpe Elizabeth D, Korenfeld Michael S, Zhang Steven, Baudouin Christophe
North Bay Eye Associates, Sonoma County, CA, USA.
John Moran Eye Center, University of Utah, Salt Lake City, UT, USA.
Clin Ophthalmol. 2023 Sep 1;17:2575-2588. doi: 10.2147/OPTH.S414015. eCollection 2023.
To evaluate the safety and efficacy of a preservative-free latanoprost 0.005% formulation (T2345) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) compared to benzalkonium chloride-preserved latanoprost 0.005% (BPL) formulation in the United States (US).
A prospective, randomized, multicenter, observer-masked, parallel-group study enrolled 335 patients diagnosed with POAG or OHT from 31 US sites who had adequately controlled intraocular pressure (IOP; ≤18 mm Hg) with latanoprost monotherapy. After a ≥72-hour washout period, patients were randomized to T2345 (n=165) or BPL (n=170) groups. Study drugs were dosed once-daily from Day 0 to Day 84 in one or both eyes. The study eye was the eye with lower IOP at baseline. The primary efficacy measure was the between-group comparison of the mean IOP values in the study eye at each time point (8 AM, 10 AM, and 4 PM on Days 15, 42, and 84). Safety measurements included ocular and systemic treatment-emergent adverse events (TEAEs).
Both T2345 and BPL adequately controlled IOP with 95% CIs within 1.5 mm Hg in the study eye at all assessed time points. The percentages of patients with diurnal IOP <18 mm Hg at Day 84 were 73.1% vs 78.7% for the T2345 and BPL groups, respectively. Adverse events were generally mild-to-moderate and primarily ocular. Fewer patients in the T2345 group experienced ocular TEAEs (13.9% vs 22.5%, respectively) and TEAEs with a suspected relationship to the study medication compared with the BPL group (5.5% vs 11.8%, respectively). The most common ocular TEAEs were instillation site pain and conjunctival hyperemia.
In patients with POAG or OHT, both T2345 and BPL maintained IOP at or below clinically meaningful values for the duration of the study. T2345 showed a favorable safety profile, with numerically lower incidences of ocular TEAEs than BPL.
在美国，比较不含防腐剂的0.005%拉坦前列素制剂（T2345）与含苯扎氯铵的0.005%拉坦前列素（BPL）制剂对原发性开角型青光眼（POAG）或高眼压症（OHT）患者的安全性和有效性。
一项前瞻性、随机、多中心、观察者设盲、平行组研究纳入了来自美国31个地点的335例被诊断为POAG或OHT的患者，这些患者使用拉坦前列素单药治疗时眼压（IOP）得到充分控制（IOP≤18mmHg）。经过≥72小时的洗脱期后，患者被随机分为T2345组（n = 165）或BPL组（n = 170）。研究药物从第0天至第84天每天给药一次，用于一只或两只眼睛。研究眼为基线时IOP较低的眼睛。主要疗效指标是在每个时间点（第15、42和84天上午8点、10点和下午4点）研究眼中平均IOP值的组间比较。安全性测量包括眼部和全身治疗中出现的不良事件（TEAE）。
在所有评估时间点，T2345和BPL均能充分控制研究眼中的IOP，95%置信区间在1.5mmHg以内。在第84天，T2345组和BPL组日间IOP<18mmHg的患者百分比分别为73.1%和78.7%。不良事件一般为轻度至中度，主要为眼部不良事件。与BPL组相比，T2345组发生眼部TEAE的患者较少（分别为13.9%和22.5%）以及与研究药物疑似相关的TEAE较少（分别为5.5%和11.8%）。最常见得眼部TEAE是滴眼部位疼痛和结膜充血。
在POAG或OHT患者中，在研究期间T2345和BPL均能将IOP维持在或低于临床有意义的水平。T2345显示出良好的安全性，眼部TEAE的发生率在数值上低于BPL。
