Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET Study)-Long Term Safety Follow-up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
研究概览
简要总结
The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).
详细描述
Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease.
The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
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
- None
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 been enrolled in the OPP-002 study
- •Have received at least one dose of the study drug/placebo in OPP-002 study
- •Completed the OPP-002 study to Visit 5
- •Have provided verbal and written informed consent
排除标准
- •Have discontinued prior to Visit 5 in the OPP-002 study.
研究组 & 干预措施
OC-01 Low Dose, 0.12 mg/mL
OC-01 (varenicline) nasal spray, 0.12 mg/mL
干预措施: OC-01 Low Dose, 0.12 mg/mL (Drug)
OC-01 Mid Dose, 0.6 mg/mL
OC-01 (varenicline) nasal spray, 0.60 mg/mL
干预措施: OC-01 Mid Dose, 0.6 mg/mL (Drug)
OC-01 High Dose, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL
干预措施: OC-01 High Dose, 1.2 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
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
时间窗: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
时间窗: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
时间窗: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
时间窗: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
次要结局
未报告次要终点