Lippa E A, von Denffer H A, Hofmann H M, Brunner-Ferber F L
Clinical Research Department, Merck Sharp & Dohme Research Laboratories, West Point, Pa 19486.
Arch Ophthalmol. 1988 Dec;106(12):1694-6. doi: 10.1001/archopht.1988.01060140866029.
A three-dose, randomized, double-masked, parallel, placebo-controlled ocular tolerance study was undertaken in 12 healthy, normal volunteers with the water-soluble, topical carbonic anhydrase inhibitor MK-927. To our knowledge, this constitutes the first administration of MK-927 to humans. Ten subjects received three drops of 2% MK-927 ophthalmic solution and two subjects received three drops of placebo (vehicle) in one randomly selected eye. Local tolerance of 2% MK-927 was acceptable and supports further clinical trials in patients. Significant intraocular pressure (IOP)-lowering activity was noted when comparing IOP four hours after first dose with that 20 hours predose in the treated eye of subjects receiving MK-927 (mean percent change in IOP, -29.7%; mean change in IOP, -4.6 mm Hg) as opposed to the same comparison for the contralateral, untreated eye (-7.2% and -1.3 mm Hg, respectively). In the two subjects treated with placebo, IOP-lowering activity was not seen in either the placebo-treated eye (-0.4%) or the contralateral, untreated eye (+3.1%).
一项针对12名健康正常志愿者开展的三剂量、随机、双盲、平行、安慰剂对照的眼部耐受性研究,使用了水溶性局部碳酸酐酶抑制剂MK - 927。据我们所知,这是MK - 927首次用于人体。10名受试者在一只随机选择的眼睛中滴入三滴2%的MK - 927眼药水,两名受试者在同一只眼睛中滴入三滴安慰剂(赋形剂)。2%的MK - 927的局部耐受性良好,支持在患者中开展进一步的临床试验。在接受MK - 927治疗的受试者的治疗眼中,将首次给药后4小时的眼压与给药前20小时的眼压进行比较时,发现眼压有显著降低活性(眼压平均变化百分比为-29.7%;眼压平均变化为-4.6 mmHg),而对侧未治疗眼的相同比较结果分别为-7.2%和-1.3 mmHg。在接受安慰剂治疗的两名受试者中,无论是接受安慰剂治疗的眼睛(-0.4%)还是对侧未治疗的眼睛(+3.1%),均未观察到眼压降低活性。