A Two Stage, Multi-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 and to Determine Common Symptoms in Contact Lens Discomfort (CLD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)
研究概览
简要总结
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
详细描述
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
For Stage 1 of the study, up to 12 participants who experience symptoms of CLD and experience concomitant meibomian gland dysfunction will complete a Screening visit followed by a hybrid concept elicitation and cognitive debriefing interview which can occur at the end of the Screening visit or up to 14 days later.
Stage 2 is a multi-center, single-masked, vehicle-controlled, randomized, parallel group study. Participants with CLD will be randomly assigned in a 1:1 ratio to receive either active AZR-MD-001 ointment/semi-solid drug (1.0%) or AZR-MD-001 vehicle for 3 months.
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
- Single (Outcomes Assessor)
盲法说明
single-masked
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
- •Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes.
- •A history of wearing soft contact lenses for at least 6 months.
- •Screening CLDEQ-8 score >12
排除标准
- •Active ocular infection (bacterial, viral, or fungal).
- •Participant is unlikely to follow study instructions or to complete all required study visit(s) or has a condition or situation that in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
- •Participant is an employee at the investigational site or is related to any member of the study staff.
- •Participation in another clinical trial involving a therapeutic drug or device within the past 30 days
研究组 & 干预措施
AZR-MD-001 1.0%
AZR-MD-001 ointment/semi-solid drug (1.0%)
干预措施: AZR-MD-001 ointment/semi-solid drug (Drug)
AZR-MD-001 vehicle
AZR-MD-001 vehicle
干预措施: AZR-MD-001 ointment/semi-solid drug (Drug)
结局指标
主要结局
Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)
时间窗: 3 months
Change from baseline to month 3 in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS)
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score
时间窗: 3 months
Change from baseline to month 3 in CLDEQ-8 total score. Scores can range from 0 (normal) to 37 (Impacted Contact Use).
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision
时间窗: 3 months
Change from baseline to month 3 in CLDEQ-8 fluctuating vision items. Scores can range from 0 (normal) to 9 (impacted vision). (summed responses to questions 3a and 3b only)
次要结局
未报告次要终点