Safety and Efficacy of a Drug Delivery System in Glaucoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 主要终点
- Mean Change in Intraocular Pressure at Day 1
研究概览
简要总结
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman 21 years of age or greater
- •Open angle glaucoma or ocular hypertension
- •Corrected visual acuity in each eye of 20/200 or better
排除标准
- •Previous glaucoma intraocular surgery or refractive surgery
- •Planned contact lens use during the study
- •Clinically significant ocular or systemic disease that might interfere with the study
- •Use of chronic corticosteroids by any route
研究组 & 干预措施
High Dose Drug Device/ bimatoprost 0.03%
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
干预措施: High Dose Drug Device (Drug)
High Dose Drug Device/ bimatoprost 0.03%
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
干预措施: bimatoprost 0.03% (Drug)
Low Dose Drug Device / bimatoprost 0.03%
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
干预措施: Low Dose Drug Device (Drug)
Low Dose Drug Device / bimatoprost 0.03%
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
干预措施: bimatoprost 0.03% (Drug)
Placebo Device / bimatoprost 0.03%
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
干预措施: Placebo Device (Drug)
Placebo Device / bimatoprost 0.03%
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
干预措施: bimatoprost 0.03% (Drug)
结局指标
主要结局
Mean Change in Intraocular Pressure at Day 1
时间窗: Baseline to Day 1
次要结局
- Mean Change in Intraocular Pressure at Day 3(Baseline to Day 3)
- Mean Change in Intraocular Pressure at Day 2(Baseline to Day 2)
- Mean Change in Intraocular Pressure at Day 4(Baseline to Day 4)
- Mean Change in Intraocular Pressure at Day 5(Day 4 to Day 5)