2024-517104-11-00已完成2 期
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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Primary Efficacy Endpoints: - Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 - Change from baseline in BCVA with contrast level of 10% at Month 18 - Change from baseline in contrast sensitivity with glare light at Month 18
研究概览
简要总结
Primary Efficacy Objective:
- To assess the efficacy of two concentrations of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with FECD
Safety Objective:
- To assess the safety of two concentrations of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with FECD
研究设计
- 分配方式
- Randomized
- 主要目的
- Arm
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible to be included in the study only if all the following criteria are met at Visit 1 (Screening):
- •Male or female, from 30 to 75 years of age, diagnosed with FECD.
- •Provide signed informed consent prior to any study procedures being performed.
- •Best-corrected visual acuity (BCVA) of +0.2 LogMAR or better (equivalent to ≥ 75 ETDRS letters, or at least Snellen 20/32) in the study eye as measured using an ETDRS chart.
- •Grade 3-5 of the Modified Krachmer scale in the study eye.
- •At least two out of three tomographic features are observed by Pentacam™, evaluated by the Investigator in the study eye: Tomographic Features: Parameter: Loss of parallel isopachs Definition: Any single isopach not being almost circular/oval or parallel to adjacent isopachs within the central 4 mm of the cornea (relative to the pupil center) Parameter: Displacement of the thinnest point of the cornea Definition: Being located outside of the inferotemporal quadrant (centered at the pupil center) or more than 1 mm from the pupil center in any quadrant. Parameter: Focal posterior corneal depression Definition: Any isolated area of depression (negative elevation relative to a sphere with best fit zone of 8 mm with float function) within the central 4 mm of the cornea (relative to the pupil center)
- •Endothelial cells are visible >50% of area in at least one image obtained by noncontact specular microscopy in the central or paracentral-peripheral area in the study eye.
排除标准
- •Ocular Conditions:
- •Monocular vision, or vision worse than +0.7 LogMAR (equivalent to < 50 ETDRS letters, or worse than Snellen 20/100) in the fellow eye;
- •No guttae in either eye (evaluated by slit-lamp and specular microscope).
- •Clinically evident stromal and/or epithelial edema in the study eye (evaluated by slit-lamp microscope).
- •Descemet folds in the study eye (evaluated by slit-lamp microscope).
- •Central cornea thickness is 630μm or more in the study eye (evaluated by Scheimpflug image).
- •Moderate/severe cataract in the study eye (mild cataract or pseudophakic eye is eligible for enrolment).
- •Evidence of any other ocular disease other than FECD in the study eye that may confound the outcome of the study (e.g., active diabetic retinopathy, posterior uveitis, age-related macular degeneration or any other maculopathy, severe myopia >10D, pterygium).
- •Non-Ocular Conditions:
- •Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications. Current or planned participation in any other clinical study involving an investigational product or device within 4 weeks prior to Visit 1 or at any time during this study.
- •History of any disease or condition that in the opinion of the study investigator may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study (e.g., recurrent corneal erosion syndrome, uncontrolled cardiovascular disease etc.).
结局指标
主要结局
Primary Efficacy Endpoints: - Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 - Change from baseline in BCVA with contrast level of 10% at Month 18 - Change from baseline in contrast sensitivity with glare light at Month 18
Primary Efficacy Endpoints: - Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 - Change from baseline in BCVA with contrast level of 10% at Month 18 - Change from baseline in contrast sensitivity with glare light at Month 18
Safety Endpoint: - Safety of DE-109D will be assessed by adverse events (AEs), slit-lamp biomicroscopy, indirect ophthalmoscopy, intraocular pressure (IOP), and laboratory tests (serum chemistry, hematology, and urinalysis).
Safety Endpoint: - Safety of DE-109D will be assessed by adverse events (AEs), slit-lamp biomicroscopy, indirect ophthalmoscopy, intraocular pressure (IOP), and laboratory tests (serum chemistry, hematology, and urinalysis).
次要结局
- Secondary Efficacy Endpoints: - Best corrected visual acuity (BCVA) with contrast level of 100% at all postbaseline visits - BCVA with contrast level of 10% at all post-baseline visits - Contrast sensitivity with glare light at all post-baseline visits - Contrast sensitivity without glare light at all post-baseline visits.
- - Change and percent change from baseline in BCVA with contrast level of 100% at all post-baseline visits - Change and percent change from baseline in BCVA with contrast level of 10% at all post-baseline visits - Change and percent change from baseline in contrast sensitivity with glare light at all post-baseline visits
- - Change and percent change from baseline in contrast sensitivity without glare light at all post-baseline visits - Change and percent change from baseline in central corneal thickness at all post-baseline visits. - Change and percent change from baseline in endothelial cell density at all post-baseline visits.
- - Change and percent change in Guttae formation (Modified Krachmer scale) at all post-baseline visits
研究者
Sushil Panda
Scientific
Santen Inc.
研究点 (2)
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