NCT06493604已完成3 期
A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3
研究概览
简要总结
A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
详细描述
Dry eye chamber challenge trial
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
- Double (Participant, Investigator)
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
- •18 years of age (either gender and any race)
- •Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form
- •Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
- •Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
排除标准
- •Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
- •Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
- •Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
- •Previous laser-assisted in situ keratomileusis surgery within the last 12 months
- •Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial
- •Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including artificial tears), gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)
研究组 & 干预措施
Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days
Experimental
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Vehicle Ophthalmic Solution administered six times over two consecutive days
Placebo Comparator
干预措施: Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3
时间窗: Day -14 to Day 2
Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"
次要结局
未报告次要终点
研究者
研究点 (1)
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