A Phase 3, Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Associated Symptoms of Dry Eye Disease (DED)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 16
- 主要终点
- Change from baseline in Meibomian Glands Yielding Liquid Secretion
研究概览
简要总结
This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
详细描述
This study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
Following a Screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio.
Study follow-up visits will be conducted on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12. Patients will exit the study approximately 13 months after the Baseline visit. Any ongoing treatment-emergent adverse events (TEAEs) will be followed for an additional 30 days following the Month 12 visit.
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 at Screening.
- •Evidence of active Evaporative DED at Screening and Baseline.
- •Evidence of meibomian gland obstruction in both eyes at Screening and Baseline.
排除标准
- •Ocular disease (except for Meibomian Gland Dysfunction (MGD) and DED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator.
- •Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24 mm Hg in either eye at Screening.
- •Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, or recurrent inflammation.
- •Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration.
研究组 & 干预措施
AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.
干预措施: AZR-MD-001 (Drug)
Vehicle
AZR-MD-001 Vehicle to be administered twice weekly at bedtime.
干预措施: Vehicle (Other)
结局指标
主要结局
Change from baseline in Meibomian Glands Yielding Liquid Secretion
时间窗: Month 3
Meibomian Glands Yielding Liquid Secretion (MGYLS) measures the number of meibomian glands (0 - 15) secreting liquid
Change from baseline in Total Ocular Surface Disease Index Score
时间窗: Month 3
The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)
次要结局
未报告次要终点