A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial With Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change From Baseline Ocular Itching Score on High Pollen Days
研究概览
简要总结
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal 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 ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
- •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 any of the investigational product medication or 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 months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
- •have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
- •have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
- •be a female who is currently pregnant, planning a pregnancy, or lactating
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
Change From Baseline Ocular Itching Score on High Pollen Days
时间窗: Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.
次要结局
未报告次要终点