Quiroz-Mercado Hugo, Ivri Ehud, Gonzalez-Salinas Roberto, Kourtis Iraklis C, Gilbert Joseph, Pérez-Vázquez José Francisco, Blumenkranz Mark, Jiménez-Román Jesús, Marcellino George
Association to Prevent Blindness, Hospital Sanchez-Bulnes, Mexico City, Mexico.
Kedalion Therapeutics Inc., Menlo Park, CA, USA.
Clin Ophthalmol. 2020 Jan 20;14:139-147. doi: 10.2147/OPTH.S221749. eCollection 2020.
Self-administration of topical ophthalmic therapies remains challenging for many patients as errors due to improper technique are common. The aim of the current studies was to evaluate a novel electromechanical topical ocular drug delivery device designed to facilitate precise dosing and accurate delivery with substantially lower drug exposure than conventional eye drops.
Two randomized Phase 1 studies were performed to evaluate the efficacy and safety of a single dose of a topical ophthalmic solution administered as a ~9 μL microfluid stream via the test device compared with a ~30-40 μL drop delivered via conventional dropper in healthy subjects (Trial 1) and glaucoma patients (Trial 2). In Trial 1, a 1% tropicamide/2.5% phenylephrine solution was administered via the test device in one eye and by conventional dropper in the contralateral eye. Pupil dilation was measured at 30 min intervals post-instillation and subject comfort was assessed using a visual analogue scale (range, 0-100). In Trial 2, patients were randomized to receive latanoprost 0.005% via the test device or conventional dropper. Intraocular pressure was measured at baseline and 4-8 hrs post-instillation.
In Trial 1 (N=20), mean (SD) pupil diameter 30 mins post-instillation increased by 3.4 (0.9) and 3.5 (1.0) mm in the test and control eyes, respectively. The mean comfort score was 81.7 for the test device versus 57.3 for conventional dropper delivery. In Trial 2 (N=18), the mean change in intraocular pressure following administration of latanoprost was -5.0 (1.8) and -4.3 (3.3) mm Hg in the test and control groups, respectively. No serious adverse events were observed in either study.
Administration of a single dose of topical ophthalmic therapy via an electromechanical drug delivery device resulted in comparable effects on pupil dilation and intraocular pressure with lower drug exposure and increased patient comfort compared with conventional dropper delivery.
由于操作不当导致的用药错误很常见，因此许多患者自行使用局部眼科治疗药物仍具有挑战性。当前研究的目的是评估一种新型机电式局部眼部给药装置，该装置旨在促进精确给药和准确递送，且与传统眼药水相比，药物暴露量显著降低。
进行了两项随机1期研究，以评估在健康受试者（试验1）和青光眼患者（试验2）中，通过测试装置以约9微升微流体流的形式给予单剂量局部眼用溶液与通过传统滴管给予约30 - 40微升滴剂相比的疗效和安全性。在试验1中，一只眼睛通过测试装置给予1%托吡卡胺/2.5%去氧肾上腺素溶液，对侧眼睛通过传统滴管给药。滴入后每隔30分钟测量瞳孔散大情况，并使用视觉模拟量表（范围0 - 100）评估受试者的舒适度。在试验2中，患者被随机分配通过测试装置或传统滴管接受0.005%拉坦前列素。在基线和滴入后4 - 8小时测量眼压。
在试验1（N = 20）中，滴入后30分钟，测试眼和对照眼的平均（标准差）瞳孔直径分别增加3.4（0.9）和3.5（1.0）毫米。测试装置的平均舒适度评分为81.7，而传统滴管给药为57.3。在试验2（N = 18）中，测试组和对照组给予拉坦前列素后眼压的平均变化分别为 - 5.0（1.8）和 - 4.3（3.3）毫米汞柱。两项研究均未观察到严重不良事件。
与传统滴管给药相比，通过机电式给药装置给予单剂量局部眼科治疗药物，在瞳孔散大和眼压方面产生了相当的效果，同时降低了药物暴露并提高了患者舒适度。
