jRCT2080224167已完成3 期
Long-term study on WP-1303 ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Non-masked, Non-comparative
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Each potential subject must satisfy all of the following criteria to be enrolled in the study.
- •Patients with POAG, normal-tension glaucoma, exfoliation glaucoma, pigmentary glaucoma or OH
- •Provision of written voluntary consent to participate in the study
- •Japanease not less than 20 years of age at informed consent
- •IOP at 9 o'clock of IOP confirmation date (-Day 14 to -Day 1) and IOP at 9 o'clock baseline (Day 0) should meet the following criteria:
- •(1)IOP is less than 35 mmHg for both eyes
- •(2)IOP at least one eye is not less than 15mmHg and the change from baseline IOP at IOP confirmation date is no more than 3 mmHg
排除标准
- •Any potential subject who meets any of the following criteria will be excluded from participating in the study.
- •Patients who have visual acuity (corrected visual acuity if correction is necessary) of less than 0.3 in one eye at screening and baseline observation period.
- •Presence of active eye disease (eg., uveitis, ocular infection, severe dry eye).
- •Anticipated use of prohibited drugs between screening and at the completion of treatment phase.
- •Anticipated wear of contact lenses in one eye between screening and at the completion of treatment phase.
- •Presence of uncontrolled systemic disease (eg., hypertension, diabetes).
结局指标
主要结局
-
safety efficacy:intraocular pressure safety:adverse event and adverse drug reaction
次要结局
未报告次要终点
研究者
研究点 (1)
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