In this double-blind, randomized clinical trial, 63 untreated Chinese patients with POAG and ocular hypertension were enrolled. All patients received LTFC and were randomized (1:1) to group 1, morning (8 AM) dosing, or group 2, evening (8 PM) dosing. Vehicle drops were used in the morning or evening, accordingly, to preserve masking. Patients were treated for 4 weeks. Outcomes included mean reduction of the 24-hour intraocular pressure (IOP) and IOP fluctuation from baseline after a 4-week treatment.
Fifty-six patients were included in the final analysis. In both groups, the posttreatment IOP values were significantly lower than those at baseline at each 24-hour measuring time point. A significant difference between the groups in IOP reduction from baseline was observed at the 9:30 AM time point (4.01 ± 2.62 vs. 2.42 ± 3.23 mm Hg, evening dosing versus morning dosing group; P = 0.048). Both groups showed decreased IOP fluctuation after treatment. However, the morning dosing group had a significantly greater decrease in diurnal IOP fluctuation than that of the evening dosing group (2.04 ± 2.32 mm Hg vs. 0.50 ± 1.70 mm Hg, respectively; P = 0.012).
Both morning and evening LTFC dosing can effectively reduce 24-hour IOP and IOP fluctuation. Morning dosing is more likely to effectively control diurnal IOP fluctuations.
This multicenter, double-blind, randomized clinical trial generates robust evidence on the optimal LTFC dosing regimen to help clinical decision-making in the treatment of raised IOP.
■在这个双盲系统中,随机临床试验,纳入63例未经治疗的POAG和高眼压中国患者。所有患者均接受LTFC,并随机(1:1)到第1组,早晨(上午8点)给药,或第2组,晚上(晚上8点)给药。车辆滴剂在早上或晚上使用,因此,保存掩蔽。患者治疗4周。结果包括治疗4周后24小时眼内压(IOP)的平均降低和IOP从基线的波动。
■56名患者被纳入最终分析。在这两组中,在每个24小时测量时间点,治疗后IOP值均显著低于基线.在9:30AM时间点观察到两组之间IOP从基线降低的显着差异(4.01±2.62vs.2.42±3.23mmHg,晚上给药组与早上给药组;P=0.048)。两组治疗后眼压波动均有所下降。然而,早晨给药组的日眼压波动下降幅度明显大于晚上给药组(2.04±2.32mmHgvs.0.50±1.70mmHg,分别;P=0.012)。
■早晚LTFC给药都可有效降低24小时IOP和IOP波动。早晨给药更可能有效控制昼夜IOP波动。
■这个多中心,双盲,随机临床试验为最佳LTFC给药方案提供了有力的证据,以帮助临床决策治疗升高的IOP.