A Single-Center, Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Mean Change in Goblet Cell Area
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.
详细描述
This was a Phase 2, single-center, randomized, masked (including all subjects, investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in stimulating goblet cell and Meibomian gland function in in adult subjects with DED. Approximately 45 subjects at least 18 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria were planned to be randomized to receive a single application of 0.2% (1.2 mg/mL) OC-01 or placebo
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1.
排除标准
- •Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1
- •Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
- •Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
- •Have a known hypersensitivity to any of the procedural agents or study drug components
- •Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
研究组 & 干预措施
OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL, one time dosing
干预措施: OC-01 (varenicline) nasal spray (Drug)
Placebo (vehicle control) nasal spray
Placebo (vehicle control) nasal spray, one time dosing
干预措施: Placebo (vehicle control) nasal spray (Drug)
结局指标
主要结局
Mean Change in Goblet Cell Area
时间窗: Baseline (pre-treatment), 1 day (post treatment)
Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.
Mean Change in Goblet Cell Perimeter
时间窗: Baseline (pre-treatment), 1 day (post treatment)
Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.
Change in Meibomian Gland Area, Upper Lid
时间窗: Baseline (pre-treatment), 1 day (post treatment)
Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome
Mean Change in Meibomian Gland Area, Lower Lid.
时间窗: Baseline (pre-treatment), 1 day (post treatment)
Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.
Mean Change in Meibomian Gland Perimeter, Upper Lid.
时间窗: Baseline (pre-treatment), 1 day (post treatment)
Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.
Mean Change in Meibomian Gland Perimeter, Lower Lid
时间窗: Baseline (pre-treatment), 1 day (post treatment)
Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.
次要结局
未报告次要终点