NCT01794312已完成3 期
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with one chronic keratitis/corneal ulcer
- •Patients who signed and dated informed consent
排除标准
- •Patient under 18 years
- •Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.
研究组 & 干预措施
T4020
Experimental
One drop every 2 days
干预措施: T4020 (Device)
Vehicle
Placebo Comparator
One drop every 2 days
干预措施: Vehicle (Device)
结局指标
主要结局
Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
时间窗: Day 28
Reduction in neurotrophic ulcer/keratitis area of 50% or more
次要结局
- Best Corrected Visual Acuity(Baseline and Day 28)
- Number of Participants With at Least One Treatment-emergent Adverse Event(From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety assessment of T4020 versus vehicle in patients with chronic neurotrophic keratitis or corneal ulcer. Phase III study, international, multicentre, randomised, double-masked, 2 parallel groups, versus vehicle, in 124 evaluable patients treated for 28 days.Chronic neurotrophische keratitis & Chronische neurotrophische corneal ulcus10015919NL-OMON44908ABORATOIRES THEA4
进行中（未招募）
1 期
Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-000846-23-LVaboratoires THEA434
进行中（未招募）
1 期
Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-000846-23-BEaboratoires THEA434
进行中（未招募）
1 期
Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-000846-23-LTaboratoires THEA668
进行中（未招募）
1 期
Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.glaucoma, ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2017-000846-23-ESaboratoires THEA485