An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects With Dry Eye Disease in a Dry Eye Chamber
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change From Baseline in Ocular Discomfort
研究概览
简要总结
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen (18) to70 years of age at the time of screening (either gender and any race).
- •Ability to provide written informed consent.
- •Reported history of dry eye for at least 6 months prior to Visit 1.
排除标准
- •Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit
- •Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial.
- •A condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial.
- •Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.
研究组 & 干预措施
Reproxalap Ophthalmic Solution (0.25%)
Single dose
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Xiidra® (5% lifitegrast ophthalmic solution)
Single dose
干预措施: Xiidra® (5% lifitegrast ophthalmic solution) (Drug)
结局指标
主要结局
Change From Baseline in Ocular Discomfort
时间窗: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Change From Baseline in Ocular Itching
时间窗: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
次要结局
未报告次要终点