Kim Joon Mo, Park Sang Woo, Seong Mincheol, Ha Seung Joo, Lee Ji Woong, Rho Seungsoo, Lee Chong Eun, Kim Kyoung Nam, Kim Tae-Woo, Sung Kyung Rim, Kim Chan Yun
Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea.
Department of Ophthalmology, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Korea.
Pharmaceuticals (Basel). 2021 May 24;14(6):501. doi: 10.3390/ph14060501.
In this study, we investigated the effect of preservative-free (PF) 0.0015% tafluprost (TA), to the preservative containing (PC) and the PF 0.005% latanoprost (LA) in Korean subjects. This study was conducted as a multi-center, randomized, investigator-blind, active controlled, parallel-group, clinical trial in adult patients (≥19 years) with open-angle glaucoma (OAG) and ocular hypertension (OHT). After a washout period, patients with an IOP between 15 and 35 mmHg were enrolled and evaluated the efficacy, safety, and compliance at 4, 8 and 12 weeks after the first administration. A total of 137 OAG and OHT patients were randomized. Statistically significant reductions in IOP were observed in all groups. Twelve weeks after each eye drop instillation, the mean IOP reduction was -4.59 ± 2.70 mmHg (-24.57 ± 13.49%) in the PC-LA group, -4.52 ± 2.17 mmHg (-24.41 ± 11.38%) in the PF-LA, and -3.14 ± 2.83 mmHg (-17.22 ± 14.57%) in the PF-TA group. The PF-LA showed significantly better responsiveness than did PF-TA. PF-LA was better tolerated than was PC-LA. There were no adverse events that led to cessation of eye drop use in any of the groups. In conclusion, IOP decreased similarly across the groups. PF-LA may provide a good choice for OAG patients with ocular surface diseases.
在本研究中,我们调查了不含防腐剂(PF)的0.0015%他氟前列素(TA)对韩国受试者中含防腐剂(PC)的0.005%拉坦前列素(LA)和不含防腐剂的PF 0.005%拉坦前列素的影响。本研究作为一项多中心、随机、研究者盲法、活性对照、平行组临床试验,在患有开角型青光眼(OAG)和高眼压症(OHT)的成年患者(≥19岁)中进行。经过洗脱期后,纳入眼压在15至35 mmHg之间的患者,并在首次给药后4周、8周和12周评估疗效、安全性和依从性。共有137例OAG和OHT患者被随机分组。所有组均观察到眼压有统计学意义的降低。每次滴眼12周后,PC-LA组的平均眼压降低为-4.59±2.70 mmHg(-24.57±13.49%),PF-LA组为-4.52±2.17 mmHg(-24.41±11.38%),PF-TA组为-3.14±2.83 mmHg(-17.22±14.57%)。PF-LA的反应性明显优于PF-TA。PF-LA的耐受性优于PC-LA。任何组均未出现导致停止使用滴眼液的不良事件。总之,各组眼压下降情况相似。PF-LA可能为患有眼表疾病的OAG患者提供一个良好的选择。