Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.
详细描述
This is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. This study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (MGD) in participants with Demodex lid infestation. Approximately 12 participants will be enrolled in each arm. The administration period will last for approximately 85 days.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- •Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites with lash epilation of the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid
排除标准
- •Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the use of lid hygiene products during the study
- •Have used systemic antihistamines within 30 days of Day 1
- •Have used artificial eyelashes, eyelash extensions, or had other cosmetic eyelash or eyelid procedures within 7 days of Day 1 or be unwilling to forego their use during the study
- •Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the duration of the study
- •Be pregnant or lactating at Day 1
研究组 & 干预措施
Study Cohort 1
Participants who were previously enrolled, dosed, and completed approximately 43 days of TID EV administration. Participants are crossed over to receive BID administration of EV for approximately 43 additional days.
干预措施: Vehicle of TP-03 (Drug)
Study Cohort 2
Participants are randomized to receive BID administration of EV for approximately 85 days.
干预措施: Vehicle of TP-03 (Drug)
Study Cohort 3
Participants are randomized to receive TID administration of EV for approximately 85 days
干预措施: Vehicle of TP-03 (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAEs)
时间窗: 85 days
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term. TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
次要结局
- Change from baseline in lower lid meibomian gland secretion score(85 days)
- Change from baseline in tear breakup time assessed via slit lamp(85 days)
- Change from baseline in lid margin erythema.(85 days)