NCT05389267进行中（未招募）1 期
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Ocular and systemic adverse events
研究概览
简要总结
The study purpose is to evaluate the safety of T4090.
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
- Double (Participant, Investigator)
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
- •Informed consent dated and signed.
- •Both eyes diagnosed open-angle glaucoma or ocular hypertension
排除标准
- •History of trauma, infection, clinically significant inflammation within the previous 6 months
- •Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- •Pregnancy or breast-feeding
研究组 & 干预措施
T4090
Experimental
干预措施: Kinezodianone R hydrochloride (Drug)
Placebo
Placebo Comparator
named "Vehicle" in the study protocol.
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular and systemic adverse events
时间窗: up to 22 days
Ocular and systemic treatment-emergent adverse events, serious TEAE, IMP-related TEAE, TEAE leading to premature IMP discontinuation.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT06394973Laboratoires Thea161
进行中（未招募）
1 期
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.Glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-002823-46-ATaboratoires THÉA; Research and Development Department143
进行中（未招募）
1 期
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.Glaucoma, ocular hypertensionMedDRA version: 20.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disordersEUCTR2017-002823-46-HUaboratoires THÉA; Research and Development Department108
进行中（未招募）
1 期
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.Glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-002823-46-BEaboratoires THÉA; Research and Development Department143
进行中（未招募）
1 期
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UDin Ocular Hypertensive or Glaucomatous Patients.EUCTR2020-003979-18-HUaboratoires THEA500