Randomized Controlled, Multicenter, Double-Masked, Parallel Phase III Trial to Evaluate the Efficacy and Safety of Lotilaner Ophthalmic Solution for the Treatment of Demodex Blepharitis in China With an Open-Label Pharmacokinetics Sub-Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LianBio LLC
- 入组人数
- 163
- 试验地点
- 21
- 主要终点
- The assessment of treatment-related adverse effects
研究概览
简要总结
The Phase III main study is a randomized, controlled, multicenter, double blind, trial to evaluate the efficacy and safety of TP-03 (lotilaner ophthalmic solution, 0.25%), for the treatment of Demodex blepharitis in Chinese patients. The PK sub-study is a single-arm, open-label trial to evaluate systemic TP-03 in whole blood following topical ocular administration
详细描述
The main study is designed to demonstrate the superiority of TP-03 compared to vehicle for the treatment of Demodex blepharitis in Chinese patients. The vehicle of TP-03 was selected as the control since there are no approved pharmaceutical treatments for Demodex blepharitis. The vehicle as the control will provide evidence that the active ingredient is responsible for the response, not the vehicle alone.
A pharmacokinetics (PK) sub-study is included in the overall study design to evaluate systemic PK parameters of TP-03 in Chinese participants with Demodex blepharitis. The PK sub-study sites are separate from those of the Phase III study as described above.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥ 18 years of age.
- •Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
- •Has blepharitis
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •Have used lid hygiene products (e.g., lid scrubs) within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study.
- •Have initiated treatment with an ocular topical prostaglandin analogue within 30 days of Screening or have any plans to change or discontinue treatment during the study
- •Pregnancy or lactation.
- •Any intraocular surgery (including ocular surface surgery, cataract surgery and intravitreal injection) or periocular surgery within 60 days prior to randomization, or any planned ocular surgical procedure during the study period
- •Have any unstable or uncontrolled, cardiac, pulmonary, renal, oncological, neurological, metabolic or other systemic condition that, in the opinion of the investigator, would possibly require the participant to seek emergent medical treatment during the course of this study. This includes, but is not limited to, unstable or uncontrolled cardiac arrhythmias, hypertension, coagulopathies, renal failure or advanced diabetes mellitus.
研究组 & 干预措施
Lotilaner Ophthalmic Solution (TP-03)
Lotilaner Ophthalmic Solution (TP-03)
干预措施: Lotilaner (Drug)
Vehicle Control
Vehicle Control
干预措施: Vehicle Control (Drug)
结局指标
主要结局
The assessment of treatment-related adverse effects
时间窗: 43 days
To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis
The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye.
时间窗: 43 days
To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis
The proportion of participants with Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43
时间窗: 43 days
To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis
次要结局
- The proportion of participants cured based on a composite of collarette score of 0 and erythema score of 0 for the upper eyelid of the analysis eye(43 days)
- Blood drug concentration of Lotilaner at Day 43(43 days)