A Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in Subjects With Neurotrophic Keratopathy (the Olympia Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 31
- 主要终点
- Mean Change From Baseline in Corneal Fluorescein Staining
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.
详细描述
Protocol OPP-102 is a Phase 2, multicenter, randomized, controlled, double- masked study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with NK. Approximately 100 subjects at least 18 years of age with a physicians' diagnosis of Stage 1 NK as defined by the Mackie Criteria and meeting all other study eligibility criteria will be randomized 1:1 and will receive OC-01 (varenicline)/ nasal spray or placebo nasal spray for 8 weeks three times daily (TID) as follows:
- OC-01 (varenicline) nasal spray, 1.2 mg/mL
- Placebo (vehicle control) nasal spray All doses will be delivered as a 50 microliter (µL) nasal spray.
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
- •Be at least 18 years of age at Visit
- •Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
- •Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
- •Schirmer's test without anesthesia ≥3 mm/ 5 minutes in the affected eye.
- •If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1.
排除标准
- •Have Stage 2 or Stage 3 NK affecting one or both eyes.
- •Have ocular graft versus host disease or Stevens-Johnson syndrome.
- •Have any active ocular infection (COVID-19 conjunctivitis, bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in the affected eye.
- •Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.
- •Have severe blepharitis and/or severe meibomian gland disease in the study eye.
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
干预措施: OC-01 (varenicline) nasal spray 1.2 mg/ml (Drug)
Placebo (vehicle control) nasal spray
Placebo (vehicle control) nasal spray
干预措施: Placebo (vehicle) nasal spray (Drug)
结局指标
主要结局
Mean Change From Baseline in Corneal Fluorescein Staining
时间窗: 8 weeks
Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).
次要结局
- Mean Change From Baseline in Visual Acuity at Week 8(8 weeks)