A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber
研究概览
简要总结
A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- 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) to 70 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 screening
- •Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening
排除标准
- •Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
- •Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
- •Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
- •Women of childbearing potential (WOCBP) who are pregnant and nursing
- •If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
- •Known allergy and/or sensitivity to reproxalap or the drug product vehicle
- •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%)
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Vehicle Ophthalmic Solution
干预措施: Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber
时间窗: The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period.
Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.
Schirmer Test Mean Change From Baseline
时间窗: The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period.
Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.
次要结局
未报告次要终点