Prospective, Non-Randomized, Open-Label, Single Center Study to Evaluate the Performance of the Travoprost Intraocular Implant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
研究概览
简要总结
To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson
- •Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.
- •Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.
- •Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site
排除标准
- •Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
- •Active ocular inflammation, infection or edema
- •Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata
研究组 & 干预措施
Cohort 1 (12-month exchange)
Travoprost Intracameral Implant Exchanged at Month 12
干预措施: Travoprost Intracameral Implant exchanged at Month 12 (Drug)
Cohort 2 (3-month exchange)
Travoprost Intracameral Implant Exchanged at Month 3
干预措施: Travoprost Intracameral Implant exchanged at Month 3 (Drug)
Cohort 3 (6-month exchange)
Travoprost Intracameral Implant Exchanged at Month 6
干预措施: Travoprost Intracameral Implant exchanged at Month 6 (Drug)
Cohort 4 (24-month exchange)
Travoprost Intracameral Implant Exchanged at Month 24
干预措施: Travoprost Intracameral Implant exchanged at Month 24 (Drug)
Cohort 5 (21-month exchange)
Travoprost Intracameral Implant Exchanged at Month 21
干预措施: Travoprost intracameral implant exchanged at Month 21 (Drug)
Cohort 6 (18-month exchange)
Travoprost Intracameral Implant Exchanged at Month 18
干预措施: Travoprost intracameral implant exchanged at Month 18 (Drug)
Cohort 7 (15-month exchange)
Travoprost Intracameral Implant Exchanged at Month 15
干预措施: Travoprost intracameral implant exchanged at Month 15 (Drug)
结局指标
主要结局
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
时间窗: month 12
concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration
时间窗: month 3
concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration
时间窗: month 6
concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration
时间窗: month 24
concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration
时间窗: month 21
concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration
时间窗: month 18
concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration
时间窗: month 15
concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS
次要结局
- Percent Residual Travoprost in Explanted Implant 12 Months Post-administration(month 12)
- Percent Residual Travoprost in Explanted Implant 3 Months Post-administration(month 3)
- Percent Residual Travoprost in Explanted Implant 6 Months Post-administration(month 6)
- Percent Residual Travoprost in Explanted Implant 24 Months Post-administration(month 24)
- Percent Residual Travoprost in Explanted Implant 21 Months Post-administration(month 21)
- Percent Residual Travoprost in Explanted Implant 18 Months Post-administration(month 18)
- Percent Residual Travoprost in Explanted Implant 15 Months Post-administration(month 15)