NCT00845299已完成2 期
An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to 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
- 40
- 主要终点
- IOP change from baseline
研究概览
简要总结
The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Over 18 years 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
- •Uncontrolled medical conditions
- •Subjects with a known sensitivity to latanoprost, BAK, or any other products required for the study
- •Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
研究组 & 干预措施
1
Experimental
Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride
干预措施: Latanoprost punctal plug (Drug)
1
Experimental
Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride
干预措施: artificial tears preserved with Benzalkonium Chloride (Drug)
2
Experimental
Latanoprost punctal plug only
干预措施: Latanoprost punctal plug (Drug)
结局指标
主要结局
IOP change from baseline
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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