JPRN-jRCT2031200226已完成3 期
A single-masked, randomized, multi-center, parallel-group, 4-week study evaluating the efficacy and safety of once daily netarsudil ophthalmic solution 0.02% compared to twice daily ripasudil hydrochloride hydrate ophthalmic solution 0.4% in Japanese subjects with primary open angle glaucoma (POAG) or ocular hypertension (OHT)
Aso Kenji0 个研究点目标入组 240 人开始时间: 2020年12月4日最近更新:
试验速览
- 阶段
- 3 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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. 20 years of age or older
- •2. Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye is acceptable)
- •3. Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye
- •4. Willingness and ability to give signed informed consent and follow study instructions
排除标准
- •Ophthalmic:
- •1. Clinically significant ocular disease
- •2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- •3. Previous glaucoma intraocular surgery
- •4. Refractive surgery in either eye
- •5. Ocular trauma
- •6. Ocular infection
- •7. Any corneal disease
- •8. Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic
- •9. Clinically significant systemic disease
- •10. Participation in any investigational study within 30 days prior to screening
- •11. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
研究者
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