Pfeiffer N, Gerling J, Lippa E A, Brunner-Ferber F L, Panebianco D, Grehn F
Universitäts-Augenklinik, Freiburg, Federal Republic of Germany.
Graefes Arch Clin Exp Ophthalmol. 1991;229(2):111-4. doi: 10.1007/BF00170540.
A single-dose, randomised, double-masked, placebo-controlled, five-period cross-over comparative ocular tolerance study was undertaken with the topical carbonic anhydrase inhibitor (CAI) MK-927 (1% and 2% concentrations) and its S-enantiomer MK-417 (1% and 1.8% concentrations) in 20 healthy, normal volunteers. Subjects received one drop of placebo (common vehicle) or CAI in each eye on five different days that were separated by washout intervals of 1 week. The incidence of burning increased significantly after treatment with 2% MK-927 (P less than 0.01) and 1.8% MK-417 (P less than 0.05) as compared with placebo. The mean duration of burning following placebo was 16.8 s, somewhat less than that following CAI application (23-37.1 s). The duration of tearing following CAI treatment was also significantly prolonged (P less than 0.05). Pupil size was not changed by CAIs. No other side effects were observed. At 3 h after instillation, intraocular pressure (IOP) was found to be decreased following all four CAI treatments, significantly so with 1% and 1.8% MK-417. The reasonable single-dose tolerability of MK-927 and MK-417 in this sensitive normal-volunteer model supports their potential as topical glaucoma medications. This study suggests that MK-417 may possess greater IOP-lowering activity than MK-927 in man.
对20名健康正常志愿者进行了一项单剂量、随机、双盲、安慰剂对照、五周期交叉比较眼耐受性研究,研究对象为局部碳酸酐酶抑制剂(CAI)MK - 927(浓度为1%和2%)及其S - 对映体MK - 417(浓度为1%和1.8%)。受试者在五个不同的日子里,每只眼睛滴一滴安慰剂(普通赋形剂)或CAI,每次给药间隔1周的洗脱期。与安慰剂相比,用2% MK - 927(P小于0.01)和1.8% MK - 417(P小于0.05)治疗后烧灼感发生率显著增加。安慰剂组烧灼感的平均持续时间为16.8秒,略短于应用CAI后的持续时间(23 - 37.1秒)。CAI治疗后流泪持续时间也显著延长(P小于0.05)。CAI对瞳孔大小无影响。未观察到其他副作用。滴药后3小时,所有四种CAI治疗后眼压(IOP)均降低,1%和1.8% MK - 417降低显著。在这种敏感的正常志愿者模型中,MK - 927和MK - 417合理的单剂量耐受性支持了它们作为局部青光眼药物的潜力。这项研究表明,在人体中MK - 417可能比MK - 927具有更强的降低眼压活性。