A 12-Month, Phase 4, Open Label, Multicenter, Trial to Assess the Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 118
- 试验地点
- 9
- 主要终点
- Mean IOP change from Baseline (11AM point)
研究概览
简要总结
The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.
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
- •Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
- •Previous history of topical beta-blocker use and insufficiently controlled IOP
排除标准
- •Pigmentary or exfoliative glaucoma
- •History of angle-closure or an occludable angle by gonioscopy
- •Prior filtration or laser iridotomy
- •Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months
- •History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease
研究组 & 干预措施
COMBIGAN®
One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months
干预措施: brimonidine tartrate/timolol malate Ophthalmic Solution (Drug)
COMBIGAN® + LUMIGAN® 0.01%
LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering.
干预措施: brimonidine tartrate/timolol malate Ophthalmic Solution (Drug)
COMBIGAN® + LUMIGAN® 0.01%
LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering.
干预措施: bimatoprost ophthalmic solution 0.01% (Drug)
结局指标
主要结局
Mean IOP change from Baseline (11AM point)
时间窗: Baseline, Month 12
次要结局
- Mean change in Mean deviation (MD) from Baseline(Baseline, Month 12)
- Mean change in Pattern standard deviation (PSD) from Baseline(Baseline, Month 12)
- Mean change in Visual field index (VFI) from Baseline(Baseline, Month 12)
- The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months(12 Months)
- Mean IOP change from Baseline (11AM point)(Baseline, Month 12)
- Mean IOP change from Baseline (9AM point)(Baseline, Month 12)
- Mean change in cup to disc ratio (C/D ratio) from Baseline(Baseline, Month 12)
- Rate of VF progression measured as change in VF index over time(Baseline, Month 12)
- Mean duration of achieving the target IOP with COMBIGAN® alone(12 Months)
- Definition of patient demographics (descriptive analysis of age and gender)(Baseline, Month 12)