A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 7
- 主要终点
- Subject-reported Ocular Itching Score
研究概览
简要总结
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
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
- 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 a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
- •have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart
排除标准
- •have known contraindications or sensitivities to the use of the investigational product or any of its components
- •have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
- •have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
- •have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
- •have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
- •be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1
研究组 & 干预措施
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)
Vehicle Ophthalmic Solution
干预措施: Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Subject-reported Ocular Itching Score
时间窗: Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
次要结局
- Number of Subjects With Two-point Reduction in Itching Score(Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.)