A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis (VISTA-1X)
Vision and Inflammation Study Testing Anti-acarid Therapeutics (VISTA-1X): A Phase 2, Open-Label, Placebo-Controlled, Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Adults With Blepharitis.
The purpose of this study is to establish the clinical efficacy of APT-001 topical therapy 1.8% in patients with blepharitis as compared to placebo, and to establish that the therapeutic is safe and generally well tolerated by patients.
研究概览
地位
条件
详细说明
This Phase 2 study is an open-label trial to compare the safety and efficacy of APT-001 1.8% to placebo control for the treatment of blepharitis. The primary objective of the study is to compare the safety and efficacy of APT-001 compared to placebo from Day 1 to Day 15 in patients with blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Josue Moran, Ph. D.
- 电话号码：512-270-3960
- 邮箱：vista@apertabio.com
学习地点
-
-
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Guatemala City、危地马拉
- EyeScan, Imágenes Diagnósticas Oculares, S. A.
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接触：
- Glendy Martinez
- 电话号码：+502 5930-5051
- 邮箱：Eyescangt@gmail.com
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首席研究员：
- Rudy Oliver Gutierrez Paz, MD
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Guatemala City、危地马拉
- Hospital de Día, Clínica de Ojos Doctor Gutiérrez
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接触：
- Ozen Martinez
- 电话号码：+502-2236-4100
- 邮箱：servicioalcliente@clinicasdrgutierrez.com
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首席研究员：
- Rudy Gutierrez Diaz, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Symptomatic blepharitis
- At least 18 years of age
- Eyelid collarette score of at least 2
- Demodex mite density of at least 1.5 mites per lash or higher
- Willing and able to follow all instructions and attend all study visit
- Able to avoid prohibited medication for the duration of the study
- Patients can willingly provide consent on the informed consent form
Exclusion Criteria:
- Women with confirmed pregnancies
- Utilizing any medical or surgical therapy for acute or subacute conditions of the eye
- History of allergic reaction to spinosad or any formulation component
- Patients using eyelid hygiene or other treatment(s) for blepharitis within 14 days of screening
- History of ocular surgery within the past 3 months
- Presence of other ocular diseases that may affect study outcomes
- Use of investigational drug, chronic glaucoma medications, or steroids
- Uncontrolled systemic disease
- Acute or chronic illness that would confound study results
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Active
APT-001 topical ophthalmic ointment, administered once |
APT-001 topical ophthalmic ointment (spinosad), administered once |
|
安慰剂比较：Placebo control for APT-001 topical ophthalmic ointment, administered once
|
Placebo control for APT-001 topical ophthalmic ointment, administered once |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Demodex mite killing
大体时间：From enrollment to last visit at 2 weeks
|
Number of living Demodex mites following treatment |
From enrollment to last visit at 2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of Collarette Cure
大体时间：From enrollment to last visit at 2 weeks
|
Eyelid collarette score 0 |
From enrollment to last visit at 2 weeks
|
|
Rate of Erythema Cure
大体时间：From enrollment to last visit at 2 weeks
|
Erythema Cure Rate |
From enrollment to last visit at 2 weeks
|
|
Average Demodex mite density
大体时间：From enrollment to last visit at 2 weeks
|
Demodex mite density |
From enrollment to last visit at 2 weeks
|
合作者和调查者
调查人员
- 研究主任：Josue Moran, Ph.D.、Aperta Biosciences, LLC
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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