Stalmans Ingeborg, Oddone Francesco, Cordeiro Maria Francesca, Hommer Anton, Montesano Giovanni, Ribeiro Luisa, Sunaric-Mégevand Gordana, Rossetti Luca
Department of Ophthalmology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Glaucoma Research Unit, G.B.Bietti Eye Foundation - IRCCS, Via Livenza 3, 00198, Rome, Italy.
Graefes Arch Clin Exp Ophthalmol. 2016 Jun;254(6):1151-8. doi: 10.1007/s00417-016-3299-9. Epub 2016 Feb 24.
The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF).
A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment.
Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs).
This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.
本研究旨在调查单剂量无防腐剂比马前列素（BUDPF）和单剂量无防腐剂拉坦前列素（LUDPF）的疗效和安全性。
采用前瞻性、随机、研究者设盲、交叉对照比较。纳入标准为眼压升高（OHT）或开角型青光眼（OAG），在使用保存的前列腺素单一疗法时，最大眼压（IOP）为21 mmHg。经过6周的洗脱期后，患者被随机分为接受BUDPF或LUDPF治疗3个月，然后换用另一种治疗3个月。在基线和每个治疗期后进行眼压曲线测量。在R编程环境中进行统计分析。使用线性混合模型来处理同一受试者的重复测量以及来自同一中心的观察值聚类。安全性结果包括视力、不良事件、裂隙灯生物显微镜检查、眼部耐受性和视神经评估。
6个月时（主要结局）的分析显示，LUDPF和BUDPF之间的眼压值差异为1.6±0.5 mmHg（p<0.01）。观察到受试者眼压平均差异为0.9±0.2 mmHg（LUDPF - BUDPF）（p<0.01）。与基线相比，两种药物在3个月和6个月时的眼压均有显著差异：3个月时，BUDPF和LUDPF的眼压均降低4.0±0.5 mmHg（两种药物p<0.01；两种药物之间p = 0.32）；6个月时，BUDPF和LUDPF分别降低5.2±0.5和3.4±0.5 mmHg（均p<0.01）。两种药物耐受性均良好，唯一具有统计学意义的差异是LUDPF的充血评分较低（尽管两种药物的充血评分都很低）。
本研究表明，在降低眼压方面，BUDPF比LUDPF具有更好的疗效。该结果在两个治疗组6个月时的平行比较以及受试者内眼压比较中均一致。
