A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 321
- 试验地点
- 29
- 主要终点
- Meibomian Glands Yielding Liquid Secretion (MGYLS)
研究概览
简要总结
AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)
详细描述
AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)
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
- •Male or female, 18 years of age or older
- •Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
- •Evidence of meibomian gland obstruction
- •Reported dry eye signs and symptoms within the past 3 months
排除标准
- •Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
- •Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study
- •Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
- •BCVA worse than 20/40 in either eye
- •Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
研究组 & 干预措施
AZR-MD-001 Low Dose
AZR-MD-001 Low Dose will be dosed up to once daily.
干预措施: AZR-MD-001 Low Dose (Drug)
AZR-MD-001 Mid Dose
AZR-MD-001 Mid Dose will be dosed up to once daily.
干预措施: AZR-MD-001 Mid Dose (Drug)
AZR-MD-001 High Dose
AZR-MD-001 High Dose will be dosed up to once daily.
干预措施: AZR-MD-001 High Dose (Drug)
AZR-MD-001 Vehicle
AZR-MD-001 Vehicle will be dosed up to once daily.
干预措施: AZR-MD-001 Vehicle (Drug)
结局指标
主要结局
Meibomian Glands Yielding Liquid Secretion (MGYLS)
时间窗: Value at month 3 minus value at baseline
Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal)
Ocular Surface Disease Index (OSDI) Total Score
时间窗: Value at month 3 minus value at baseline
Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal)
次要结局
未报告次要终点