Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 758
- 试验地点
- 21
- 主要终点
- Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)
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 on signs and symptoms of dry eye disease.
详细描述
This was a Phase 3, multicenter, randomized, controlled, double-masked (including subjects, Investigators, study site personnel, and Sponsor personnel) study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray 0.6 mg/mL and 1.2 mg/mL in adult participants with DED. The study randomized 758 subjects at least 22 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria to receive OC-01 (varenicline) nasal spray or placebo twice daily (BID) for 28 days with three additional long-term follow-up visits at 6 weeks, 6 months, and 12 months. Participants who terminated from the study during the treatment period were asked to complete safety assessments (if the participants agree) prior to study exit. Participants who were terminated early from the study were not replaced
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) or extraocular surgery 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
- •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 dry eye disease 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 Low Dose, 0.6 mg/mL
OC-01 (varenicline) nasal spray, 0.6 mg/ML
干预措施: OC-01 (varenicline) nasal spray (Drug)
OC-01 High Dose, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/ML
干预措施: OC-01 (varenicline) nasal spray (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
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)
时间窗: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
次要结局
- Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2(14 Days [Visit 1 (baseline) and Visit 3 (14 days)])
- Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28(28 Days [Visit 1 (baseline) and Visit 4b (28 days)])
- Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1(7 Days [Visit 1 (baseline) and Visit 2 (7 days)])
- Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28(28 Days [Visit 1 (baseline) and Visit 4b (28 days)])
- Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes(28 Days [Visit 1 (baseline) and Visit 4a (28 days)])