A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of HBM9036 Ophthalmic Solution Versus Placebo in Subjects With Moderate to Severe Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Inferior Corneal Staining (ICS) Score
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye
详细描述
HBM9036 is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment.
A total of 100 subjects are expected to be randomized. Subjects will be randomized 1:1 at Visit 2 to HBM9036 Ophthalmic Solution or placebo group, bilaterally BID for eight weeks. The primary efficacy endpoint is sign changes from baseline in change from pre- to post-CAE inferior corneal staining score (ICSS) of the study eye evaluated at week 8 .
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
- 是
入选标准
- 未提供
排除标准
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months, or had femtosecond small incision lenticule extraction (SMILE) within the last 12 months, or had phacoemulsification within the last 3 months, or had dry eye or aggravation of dry eye caused by other ocular operations has not been stable;
- •Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;
研究组 & 干预措施
HBM9036 0.25% Ophthalmic Solution
HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
干预措施: HBM9036 0.25% Ophthalmic Solution (Drug)
Placebo Ophthalmic Solution
placebo, Ophthalmic Solution, twice a day, in the morning and evening
干预措施: placebo (Drug)
结局指标
主要结局
Inferior Corneal Staining (ICS) Score
时间窗: 8 weeks
Inferior corneal staining score, assessed by Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale (0-4 point, higher is worse) Change from baseline in change from pre- to post- CAE at Visit 6 (higher is worse)
次要结局
- Ocular Discomfort Score(8 weeks)