Bacharach Jason, Doan Long V, Stephens Kerry G, Usner Dale W, Kothe Angela C, Katz L Jay, Navratil Tomas
North Bay Eye Associates, Inc., 104 Lynch Creek Way, Suite 15, Petaluma, CA, 94954, USA.
Glaukos Corporation, One Glaukos Way, Aliso Viejo, CA, 92656, USA.
Ophthalmol Ther. 2024 Sep;13(9):2357-2367. doi: 10.1007/s40123-024-00992-1. Epub 2024 Jul 10.
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.
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.
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).
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.
ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.
本研究旨在分析和比较缓释型曲伏前列素前房内植入物与局部用前列腺素类似物（PGA）单药治疗对眼压（IOP）的治疗效果，该研究针对的是在曲伏前列素前房内植入物的两项关键3期试验入组前接受过研究前PGA单药治疗的受试者亚组。
来自两项3期试验的133名受试者组成的联合研究人群，在筛查时接受局部PGA单药治疗，随后停用局部PGA进行洗脱期，然后随机分组并给予缓释型曲伏前列素前房内植入物。分析受试者研究前局部PGA单药治疗和研究中缓释型曲伏前列素前房内植入物对眼压的治疗效果。采用配对t检验比较筛查时减去洗脱期后基线眼压与第3个月减去洗脱期后基线眼压的差异。将给予缓释型曲伏前列素前房内植入物的眼的降眼压疗效与研究入组前局部PGA单药治疗时同一眼的降眼压情况进行比较。
研究前局部PGA单药治疗和缓释型曲伏前列素前房内植入物的眼压治疗效果分别为-5.76 mmHg和-7.07 mmHg。相对于研究前PGA单药治疗，缓释型曲伏前列素前房内植入物的降眼压治疗效果显著更大，差值为1.31 mmHg（95%置信区间：-2.01，-0.60；P = 0.0003）。
与研究前局部PGA单药治疗相比，缓释型曲伏前列素前房内植入物显示出更优的降眼压治疗效果，其优势幅度具有统计学意义和临床意义。与研究前局部PGA单药治疗相比，使用缓释型植入物时眼压从基线降低得更多，这可能反映了缓释型曲伏前列素前房内植入物实现了优化的依从性以及PGA治疗药物持续释放至前房。
ClinicalTrials.gov标识符，NCT03519386和NCT03868124。
