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临床试验/NCT06389214
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

Aldeyra Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年4月9日最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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