Shen Lee Bridgitte, Malhotra Ranjan, Sall Kenneth, Mitchell Brittany, Peace James
Vision Optique, Houston, TX, USA.
Ophthalmology Associates, St. Louis, MO, USA.
Clin Ophthalmol. 2022 Jul 19;16:2285-2293. doi: 10.2147/OPTH.S367756. eCollection 2022.
To evaluate the long-term safety of latanoprost benzalkonium chloride (BAK)-free vs currently marketed latanoprost 0.005% ophthalmic solution containing BAK (referred to as reference), to treat open-angle glaucoma (OAG) or ocular hypertension (OHT).
This phase 3, multicenter, open-label, nonrandomized, single group assignment, safety study included patients who previously completed a phase 3 noninferiority study. Patients self-administered 1 drop of latanoprost BAK-free nightly for 36 weeks in the affected eye(s). Intraocular pressure (IOP), visual acuity (VA), and slit lamp biomicroscopy were assessed predose at baseline and Days 28, 56, 84, 112, 140, and 168; dilated ophthalmoscopy and visual field (VF) at baseline and Day 168. Adverse events (AEs) were recorded throughout the study.
A total of 161 patients who previously received latanoprost BAK-free (n = 80) or reference (n = 81) were enrolled. Latanoprost BAK-free maintained lowered IOP for both the study and nonstudy eye in all patients relative to baseline throughout the study. Clinically significant retinal or optic nerve changes were identified in 5 patients (1 mild-to-moderate change, prior latanoprost BAK-free; 4 mild changes, prior reference). No clinically important changes were identified for VA, slit lamp biomicroscopy, and VF measurements. Ocular AEs occurred in 66 (82.5%) vs 74 (91.4%) patients on prior latanoprost BAK-free and reference, respectively; the most frequent being eye pain (50.0% vs 64.2%) and ocular hyperemia (47.5% vs 54.3%). Most AEs were mild. There were 5 serious systemic AEs in 5 patients (n = 3, prior latanoprost BAK-free; n = 2, prior reference); all were considered unrelated or not likely related to treatment. One patient (prior reference) discontinued due to follicular conjunctivitis. There were no deaths or serious ocular AEs.
Latanoprost BAK-free was well tolerated. These findings support the chronic use of latanoprost BAK-free to treat OAG or OHT.
NCT00945958.
评估不含苯扎氯铵（BAK）的拉坦前列素与目前市售的含BAK的0.005%拉坦前列素眼用溶液（称为对照品）治疗开角型青光眼（OAG）或高眼压症（OHT）的长期安全性。
这项3期、多中心、开放标签、非随机、单组分配的安全性研究纳入了先前完成3期非劣效性研究的患者。患者每晚在患眼自行滴注1滴不含BAK的拉坦前列素，持续36周。在基线、第28、56、84、112、140和168天给药前评估眼压（IOP）、视力（VA）和裂隙灯生物显微镜检查；在基线和第168天进行散瞳眼底检查和视野（VF）检查。在整个研究过程中记录不良事件（AE）。
共有161例先前接受过不含BAK的拉坦前列素（n = 80）或对照品（n = 81）的患者入组。在整个研究过程中，相对于基线，不含BAK的拉坦前列素在所有患者的研究眼和非研究眼中均维持眼压降低。5例患者（1例轻度至中度改变，先前使用不含BAK的拉坦前列素；4例轻度改变，先前使用对照品）出现具有临床意义的视网膜或视神经改变。VA、裂隙灯生物显微镜检查和VF测量未发现具有临床重要意义的改变。先前使用不含BAK的拉坦前列素和对照品的患者中，分别有66例（82.5%）和74例（91.4%）发生眼部AE；最常见的是眼痛（50.0%对64.2%）和眼部充血（47.5%对54.3%）。大多数AE为轻度。5例患者出现5例严重全身性AE（n = 3，先前使用不含BAK的拉坦前列素；n = 2，先前使用对照品）；所有均被认为与治疗无关或不太可能与治疗相关。1例患者（先前使用对照品）因滤泡性结膜炎停药。无死亡或严重眼部AE。
不含BAK的拉坦前列素耐受性良好。这些发现支持长期使用不含BAK的拉坦前列素治疗OAG或OHT。
NCT00945958。
