Abstract：
BACKGROUND: This study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of the slow-eluting (SE) travoprost intracameral implant to the IOP treatment effect of topical prostaglandin analog (PGA) monotherapy in a subgroup of subjects who were on pre-study PGA monotherapy prior to enrollment in the two pivotal phase 3 trials of the travoprost intracameral implant.
METHODS: A combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry.
RESULTS: Pre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76 mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31 mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003).
CONCLUSIONS: The SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant.
BACKGROUND: ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.
METHODS: A combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry.
RESULTS: Pre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76 mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31 mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003).
CONCLUSIONS: The SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant.
BACKGROUND: ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.
摘要：
背景：本研究的目的是分析和比较慢洗脱（SE）曲伏前列素前房内植入术的眼压（IOP）治疗效果与局部前列腺素类似物（PGA）单药治疗的IOP治疗效果，这些受试者在纳入曲伏前列素前房内植入术的两项关键3期临床试验之前正在进行研究前PGA单药治疗。
方法：一项来自两项3期试验的133名受试者的组合研究人群，他们在筛查时接受局部PGA单一疗法，随后经历了局部PGA的冲洗期，然后随机分配并给予SE曲伏前列素前房植入物。分析受试者的研究前局部PGA单一疗法和研究中SE曲伏前列素前房内植入物的IOP治疗效果。配对t检验用于比较筛选减去冲洗后基线IOP与第3个月减去冲洗后基线IOP的差异。将施用SE曲伏前列素前房内植入物的眼睛中的IOP降低功效与在进入研究之前在局部PGA单一疗法中的同一只眼睛中的IOP降低进行比较。
结果：预研究局部PGA单药治疗和SE曲伏前列素前房植入物显示IOP治疗效果为-5.76mmHg和-7.07mmHg，分别。与研究前PGA单药治疗相比，SE曲伏前列素前房内植入物的降低IOP的治疗效果显着提高了1.31mmHg（95％置信区间：-2.01，-0.60；P=0.0003）。
结论：与研究前的局部PGA单药治疗相比，SE曲伏前列素前房内植入术显示出更好的降低IOP的治疗效果，具有统计学上的显著性和临床意义。与研究前局部PGA单一疗法相比，SE植入物上的IOP从基线降低更大，这可能反映了SE曲伏前列素前房植入物实现的PGA疗法的最佳依从性和连续洗脱到前房中。
背景：ClinicalTrials.gov标识符，NCT03519386和NCT03868124。
方法：一项来自两项3期试验的133名受试者的组合研究人群，他们在筛查时接受局部PGA单一疗法，随后经历了局部PGA的冲洗期，然后随机分配并给予SE曲伏前列素前房植入物。分析受试者的研究前局部PGA单一疗法和研究中SE曲伏前列素前房内植入物的IOP治疗效果。配对t检验用于比较筛选减去冲洗后基线IOP与第3个月减去冲洗后基线IOP的差异。将施用SE曲伏前列素前房内植入物的眼睛中的IOP降低功效与在进入研究之前在局部PGA单一疗法中的同一只眼睛中的IOP降低进行比较。
结果：预研究局部PGA单药治疗和SE曲伏前列素前房植入物显示IOP治疗效果为-5.76mmHg和-7.07mmHg，分别。与研究前PGA单药治疗相比，SE曲伏前列素前房内植入物的降低IOP的治疗效果显着提高了1.31mmHg（95％置信区间：-2.01，-0.60；P=0.0003）。
结论：与研究前的局部PGA单药治疗相比，SE曲伏前列素前房内植入术显示出更好的降低IOP的治疗效果，具有统计学上的显著性和临床意义。与研究前局部PGA单一疗法相比，SE植入物上的IOP从基线降低更大，这可能反映了SE曲伏前列素前房植入物实现的PGA疗法的最佳依从性和连续洗脱到前房中。
背景：ClinicalTrials.gov标识符，NCT03519386和NCT03868124。
