Vision and Inflammation Study Testing Anti-acarid Therapeutics (VISTA-1): A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Collarette Cure
研究概览
简要总结
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 its vehicle control, and to establish that the therapeutic is safe and generally well tolerated by patients.
详细描述
This Phase 2 study is a randomized, controlled, double-blind trial to compare the safety and efficacy of APT-001 1.8% to vehicle control for the treatment of blepharitis. The primary objective of the study is to compare the safety and efficacy of APT-001 compared to its vehicle from Day 1 to Day 43 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic blepharitis.
- •At least 6 years of age.
- •Eyelid collarette count (minimum score 2).
- •Willing and able to follow all instructions and attend all study visits.
- •Able to avoid prohibited medication for the duration of the study.
- •Patients can willingly provide consent or have a legal authorized representative provide consent on the informed consent (IC) Form.
排除标准
- •Women with confirmed pregnancies.
- •Utilizing any current medical therapy for 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 1 year.
- •Presence of other ocular diseases that may affect study outcomes (Corneal Dystrophies, Salzmanns disease, Severe dry eye, Keratoconus, Glaucoma filtering blebs).
- •Use of investigational drug, chronic glaucoma medications, steroid.
- •Uncontrolled systemic disease.
- •Acute or chronic illness that would confound study results.
研究组 & 干预措施
Active
APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
干预措施: APT-001 topical ophthalmic ointment (spinosad) (Drug)
Control
Vehicle control of APT-001 topical ophthalmic ointment, administered once daily for approximately 43 days
干预措施: Vehicle control for APT-001 topical ophthalmic ointment (Drug)
结局指标
主要结局
Collarette Cure
时间窗: From enrollment to the end of treatment at 6 weeks
Eyelid collarette count score 0
次要结局
- Overall reduction in combined eyelid collarette and erythema scores(From enrollment to the end of treatment at 6 weeks)
- Erythema Cure rate(From enrollment to the end of treatment at 6 weeks)
- Combined Cure rate(From enrollment to the end of treatment at 6 weeks)
- Demodex mite density(From enrollment to the end of treatment at 6 weeks)
- Time to a Combined Cure.(From enrollment to the end of treatment at 6 weeks)