NCT00967811已完成2 期
An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- IOP change from baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over 18 years of age diagnosed with ocular hypertension or open-angle glaucoma
- •Subjects who have a best corrected visual acuity of 20/100 or better
排除标准
- •Subjects who wear contact lenses
- •Subjects who have uncontrolled medical conditions
- •Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular topical medications
- •Subjects who have a history of chronic or recurrent inflammatory eye disease
研究组 & 干预措施
1. Formulation E1
Experimental
Formulation E1 of Latanoprost-PPDS
干预措施: Formulation E1 of L-PPDS (Drug)
2. Formulation E2
Experimental
Formulation E2 of Latanoprost-PPDS
干预措施: Formulation E2 of L-PPDS (Drug)
结局指标
主要结局
IOP change from baseline
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
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