JPRN-UMIN000021601已完成未知
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 syndrome - 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 syndrome
TT Bio-Pharma Co., Ltd.0 个研究点目标入组 20 人开始时间: 2016年3月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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 history of allogeneic hematopoietic stem cell transplantation 2. Patients who had a 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 history of Sjogren's syndrome 5. Patients who have a history of Stevens-Johnson syndrome 6. Patients who have a history of ocular cicatricial pemphigoid 7. Patients who have a history of chemical or thermal burns 8. Patients who have a history of eye diseases other than dry eye including blepharitis, lagophthalmos, eyelid failure, iritis, pterygium and glaucoma (exceptcataract). 9. Patients who have a history of systemic disease that causes dry eye 10. Patients who have a medication use that would cause dry eyes 11. Patients who have a punctal plug or had it removed within 3 months before the screening examination 12. Patients who had a operation to the ocular surface within 12 months or intraocular surgery within the 3 months before the screening period. 13. Patients who have a history of serious hepatic, renal, or digestive disorders 14. Patients who have a history of serious hematologic disorders or cardiovascular diseases 15. Patients who have complicated malignant neoplasm such as cancer or tumor occurring within 5 years prior to informed consent 16. Patients of women in breast-feeding or of pregnant 17. Patients who participated in another clinical study within 3 months prior to informed consent 18. Patients who have a drug dependency or a history of drug abuse 19. Patients are hypersensitivity to any drug ingredients (Diclofenac Sodium, fluorescein and lissamine green, etc) 20. Patients determined for other reasons not to be suitable to enter the current clinical study safely by the PI or subinvestigators (SIs).
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