NCT06389214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
- 132
- 试验地点
- 1
- 主要终点
- Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4
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
- 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 to 70 years of age at the time of screening (either gender and any race)
- •Ability to provide written informed consent
- •Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
- •Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to Visit 1
排除标准
- •Clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at Visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the Investigator, may interfere with trial conduct or assessments
- •Diagnosis at Visit 1 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 trial conduct or assessments
- •Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
- •Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of Visit 1
- •Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapy during the trial
- •Eye drop use within 2 weeks of Visit 1 and/or an unwillingness to discontinue any topical ophthalmic prescription or over-the-counter solutions, 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 2 and Visit 4
时间窗: From 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)
Loading locations...
相似试验
已完成
3 期
A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye DiseaseDry Eye DiseaseNCT06493604Aldeyra Therapeutics, Inc.116
已完成
2 期
A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye DiseaseDry Eye SyndromesNCT05424549Aldeyra Therapeutics, Inc.63
已完成
3 期
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye DiseaseDry Eye DiseaseNCT04735393Aldeyra Therapeutics, Inc.757
已完成
3 期
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic ConjunctivitisAllergic ConjunctivitisNCT03494504Aldeyra Therapeutics, Inc.318
已完成
2 期
A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular DementiaAlzheimer's Disease or Vascular DementiaNCT02886494Charsire Biotechnology Corp.80