A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD) - PHANTOM Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 86
- 试验地点
- 24
- 主要终点
- Change from baseline in BCVA with contrast level of 10% at Month 18
研究概览
简要总结
This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female diagnosed with FECD.
排除标准
- •Females who are pregnant or lactating.
- •Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye.
研究组 & 干预措施
Placebo Vehicle BID
干预措施: Placebo (Vehicle) BID (Drug)
STN1010904 ophthalmic suspension 0.1% BID
干预措施: STN1010904 ophthalmic suspension 0.1% BID (Drug)
STN1010904 ophthalmic suspension 0.03% BID
干预措施: STN1010904 ophthalmic suspension 0.03% BID (Drug)
结局指标
主要结局
Change from baseline in BCVA with contrast level of 10% at Month 18
时间窗: at 18 month
Change from baseline in contrast sensitivity with glare light at Month 18
时间窗: at 18 month
Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18
时间窗: at 18 month
Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18
时间窗: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Change From Baseline in BCVA With Contrast Level of 10% at Month 18
时间窗: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 10% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Change From Baseline in Contrast Sensitivity With Glare Light at Month 18
时间窗: The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.
This measure evaluates the change in contrast sensitivity under glare conditions from baseline to Month 18. Baseline is defined as the measurement obtained prior to the first dose at Visit 2, or the last available pre-dose measurement if Visit 2 data are unavailable. The change is calculated as the difference between the Month 18 value and the baseline value. AULCSF is calculated using the below steps: Measure contrast sensitivity (CS) at several spatial frequencies (cpd, cycles per degree). For example, at spatial frequencies of 3, 6, 12, 18. Convert the corresponding contrast sensitivity to log10 scale. Convert spatial frequencies to log10 scale. For example, log10(3), log10(6), log10(12), log10(18). Calculate the area using trapezoidal rule. Therefore, the actual measurement of AULCSF is log CS × log(cpd). For simplification, we referred to this as log scale. Higher AULCSF indicates better contrast sensitivity and better visual function.
次要结局
- Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits(up to month 18)
- Contrast sensitivity with glare light at all post-baseline visits(up to month 18)
- BCVA with contrast level of 10% at all post-baseline visits(up to month 18)
- Contrast sensitivity without glare light at all post-baseline visits(up to month 18)