An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Subject-Reported Ocular Itching Score
研究概览
简要总结
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
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 —（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 of either gender and any race
- •have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
- •have a positive skin prick test to ragweed pollen within the past year of screening
排除标准
- •known contraindication or hypersensitivities to any components of the investigational product medication or components
- •history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- •presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
- •presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
- •presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
- •diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
- •woman of childbearing potential who is pregnant or nursing
研究组 & 干预措施
Vehicle Ophthalmic Solution
干预措施: Vehicle Ophthalmic Solution (Drug)
Reproxalap Ophthalmic Solution (0.25%)
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Reproxalap Ophthalmic Solution (0.5%)
干预措施: Reproxalap Ophthalmic Solution (0.5%) (Drug)
结局指标
主要结局
Subject-Reported Ocular Itching Score
时间窗: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
次要结局
- Subject-Reported Ocular Tearing Score(Efficacy was assessed from 0 to 212 minutes in the allergen chamber.)
- Investigator-Assessed Conjunctival Redness Score(Efficacy was assessed from 0 to 210 minutes in the allergen chamber.)