NCT07778888尚未招募2 期
Phase 2a Masked Trial to Identify the Lowest Effective Concentration of BL1107 for Conjunctival Hyperemia in Patients With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Primary Part 2: Proportion of participants with complete resolution in conjunctival hyperemia at 8 hours, in each evaluated concentration of BL1107
研究概览
简要总结
Trial RX01-BL1107-1202 is designed to identify the lowest effective concentration of BL1107 required for complete resolution of conjunctival hyperemia in participants with DED. Participants will be masked to concentration of BL1107 received.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Documented diagnosis of dry eye disease
- •Conjunctival hyperemia in both eyes, without clinical signs of infection or allergic conjunctivitis
排除标准
- •Any active ocular disease
- •Anticipated wearing of contact lenses during study
- •Additional criteria per protocol
研究组 & 干预措施
BL1107 is sterile ophthalmic solution to be administered at varying concentrations
Experimental
干预措施: BL1107 (Drug)
结局指标
主要结局
Primary Part 2: Proportion of participants with complete resolution in conjunctival hyperemia at 8 hours, in each evaluated concentration of BL1107
时间窗: Assessed at 8 hours
Primary Part 1: Proportion of participants with complete resolution in conjunctival hyperemia at 30 minutes, in each evaluated concentration of BL1107.
时间窗: Assessed at 30 minutes
次要结局
未报告次要终点
研究者
相似试验
尚未招募
2 期
A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)Squamous Non-small-cell Lung CancerNCT07739199Sichuan Baili Pharmaceutical Co., Ltd.200
招募中
2 期
A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung CancerExtensive-stage Small-cell Lung CancerNCT07654400Sichuan Baili Pharmaceutical Co., Ltd.36
已完成
不适用
Device for Alleviating Temporomandibular Joint (TMJ) PainNCT07624539BTL Industries Ltd.31
尚未招募
1 期
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid TumorsDigestive Tract TumorsSolid TumorsGastrointestinal TumorsNCT07780318Sichuan Baili Pharmaceutical Co., Ltd.60
尚未招募
2 期
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus ComplexNCT07431307BioVersys AG120