A Phase 2, Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety and Tolerability 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
- 已完成
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- Adverse events during screening & treatment period
研究概览
简要总结
In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID.
The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.
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)
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
- •Individuals aged 18 years or older
- •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
- •A tear film break-up time (TFBUT) of ≤ 5 seconds in the study eye
- •A corneal fluorescein staining score of ≥ 2 in at least one region of the cornea
- •A sum corneal fluorescein staining score of ≥ 4 in the study eye
- •A total lissamine green conjunctival score of ≥ 2 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
- •Any keratorefractive surgery within the last 12 months
- •Any intraocular or extraocular surgery within 3 months
研究组 & 干预措施
TL-925 Arm
TL-925 will be administered OU BID
干预措施: TL-925 (Drug)
Placebo Arm
Placebo will be administered OU BID
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events during screening & treatment period
时间窗: Baseline to the end of day 29 (±2 days)
次要结局
- Change from baseline in corneal and conjunctival staining(Baseline to the end of day 29 (±2 days))
- Change from baseline in ocular discomfort(Baseline to the end of day 29 (±2 days))
- Change from baseline visual acuity(Baseline to the end of day 29 (±2 days))