JPRN-UMIN000036467已完成2 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Diclofenac Sodium Eye-Drops (LT-4002) in Patients with dry eye syndrome - Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Diclofenac Sodium Eye-Drops (LT-4002) in Patients with dry eye syndrome
TT Bio-Pharma Co., Ltd.0 个研究点目标入组 240 人开始时间: 2019年4月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients who had a past history of allogeneic hematopoietic stem cell transplantation 2. Patients who had a past history of refractive corneal surgery within 6 months prior to screening examination 3. Patients with contact lens use during clinical study 4. Patients who have a past history or present history of Sjogren's syndrome, Stevens-Johnson syndrome and ocular cicatricial pemphigoid 5. Patients who have a past history or present history of chemical or thermal burns 6. Patients who have a history of present illness of eye diseases other than dry eye including lagophthalmos, eyelid failure and pterygium 7. Patients who have a history of present illness of eye diseases other than dry eye requiring treatment or under treatment during the clinical study (including blepharitis, iritis, glaucoma and cataract) 8. Patients who have a present history of systemic disease that causes dry eye 9. Patients who have a medication use that would cause dry eyes 10. Patients who have a punctal plug or had it removed within 3 months before the screening examination 11. Patients who had a operation to the ocular surface within 12 months or intraocular surgery within the 3 months before the screening period. 12. Patients who have a present history of serious hepatic, renal, or digestive disorders 13. Patients who have a present history of serious hematologic disorders or cardiovascular diseases 14. Patients who have a past history or present history that may cause recurrence of malignant tumor 15. Patients of women in breast-feeding or of pregnant 16. Patients who participated in another clinical study within 3 months prior to informed consent 17. Patients who have a drug dependency or a history of drug abuse 18. Patients are hypersensitivity to any drug ingredients (Diclofenac Sodium, fluorescein and lissamine green, etc) 19. Patients determined for other reasons not to be suitable to enter the current clinical study safely by the PI or subinvestigators (SIs).
研究者
相似试验
已完成
不适用
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosisidiopathic pulmonary fibrosisJPRN-UMIN000009572TT Bio-Pharma Co., Ltd.96
已完成
不适用
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Diclofenac Sodium Eye-Drops (LT-0303) in Patients with dry eye syndromedry eye syndromeJPRN-UMIN000021601TT Bio-Pharma Co., Ltd.20
招募中
1 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Nested Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARCT-810 in Adolescent and Adult Participants with Ornithine Transcarbamylase DeficiencyMedDRA version: 21.1Level: LLTClassification code 10013373Term: Disorders of urea cycle metabolismSystem Organ Class: 100000004850Ornithine transcarbamylase deficiencyEUCTR2021-001081-38-ITArcturus Therapeutics, Inc.24
进行中（未招募）
1 期
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Nested Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARCT-810 in Adolescent and Adult Participants with Ornithine Transcarbamylase DeficiencyMedDRA version: 26.0Level: LLTClassification code 10013373Term: Disorders of urea cycle metabolismSystem Organ Class: 100000004850Ornithine transcarbamylase deficiencyEUCTR2021-001081-38-SEArcturus Therapeutics, Inc.24
进行中（未招募）
1 期
A Multi-dose Study of an Investigational Treatment to Evaluate Safety, Tolerability, and Ability to Improve Urea Cycle Function in Adolescents and Adults with Ornithine Transcarbamylase DeficiencyOrnithine transcarbamylase deficiencyEUCTR2021-001081-38-ESArcturus Therapeutics, Inc.24