Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Schirmer's Test Score at Day 1
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
详细描述
This was a Phase 2, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 02 Nasal Spray in adult participants with dry eye disease. Approximately 160 subjects, at least 22 years of age, with a subject-reported history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo at Visit 1 and Visit 2.
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
- 22 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 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
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
干预措施: 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) (Drug)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
干预措施: 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) (Drug)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
干预措施: 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) (Drug)
Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray
干预措施: Placebo (vehicle) nasal spray (Drug)
结局指标
主要结局
Schirmer's Test Score at Day 1
时间窗: Day 1 (Pre to Post-Treatment Change)
The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Eye Dryness Score at Visit 2
时间窗: Day 15 (Pre to Post-Treatment Change)
Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.
次要结局
未报告次要终点