A Phase 2b, Multicenter, Randomized, Double-masked Vehicle-controlled Study to Evaluate the Efficacy and Safety of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 880
- 试验地点
- 17
- 主要终点
- To evaluate the efficacy of TL-925 compared to vehicle on tear production
研究概览
简要总结
In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 880 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or vehicle as topical ophthalmic eye drops administered bilaterally BID.
The study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Sponsor, Investigators and study staff will be masked during the randomization process and throughout the study. The study site will have the capacity to unmask participants in an emergency.
Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject and the database has been locked.
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
- •A diagnosis of dry eye disease for at least 6 months
- •An unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye
- •Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study
排除标准
- •Any clinically significant slit lamp finding
- •Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation
- •Best-corrected visual acuity ≥0.7 logarithm of the minimum angle of resolution
- •Any keratorefractive surgery within the last 12 months
- •Any intraocular or extraocular surgery within 3 months
- •Any blepharoplasty or corneal transplant in either eye
- •Any form of punctual, or intracanalicular occlusion in either eye
- •History or presence of any ocular disorder that may interfere with study results
研究组 & 干预措施
TL-925 Arm
TL-925 will be administered OU BID
干预措施: TL-925 (Drug)
Vehicle Arm
Vehicle will be administered OU BID
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the efficacy of TL-925 compared to vehicle on tear production
时间窗: Baseline to Day 29
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score
次要结局
未报告次要终点