NCT01229982已完成2 期
A Phase 2 Study Evaluating Safety and Efficacy 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
- 121
- 试验地点
- 1
- 主要终点
- IOP change from baseline at 4 weeks
研究概览
简要总结
The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure 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
- Single Group
- 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
- •Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
- •Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.
排除标准
- •Functionally significant vision loss, or progressive field loss within the last year.
- •Contact lens wear at any time during the treatment period.
- •Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
- •Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
- •Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
- •Currently on chronic ocular topical medications
- •Currently on any ophthalmic or systemic steroid therapy.
- •Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
- •History of macular edema
- •History of chronic/recurrent inflammatory eye disease.
- •History of a non-response to topical prostaglandin therapy.
- •Subjects who have epiphora.
研究组 & 干预措施
L-PPDS
Experimental
干预措施: Latanoprost-PPDS (Drug)
结局指标
主要结局
IOP change from baseline at 4 weeks
时间窗: Baseline to 4 Weeks
4 Weeks minus baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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