A Phase II Multi-center, Randomized Study to Evaluate the Monocular Addition of Trabodenoson (INO-8875) Ophthalmic Formulation to Latanoprost Ophthalmic Solution Therapy in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).
详细描述
Criteria
Inclusion Criteria:
- Subject has signed and dated the current informed consent form (ICF).
- Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
- Aged 18 or older.
- Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.
Exclusion Criteria:
- No significant visual field loss or any new field loss within the past year.
- Cup-to-disc ratio ≥0.8
- Central corneal thickness <500 µm or >600 µm
- A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject has signed and dated the current informed consent form (ICF).
- •Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
- •Aged 18 or older.
- •Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.
排除标准
- •No significant visual field loss or any new field loss within the past year.
- •Cup-to-disc ratio ≥0.8
- •Central corneal thickness <500 µm or >600 µm
- •A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
研究组 & 干预措施
Trabodenoson Plus Latanoprost
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
干预措施: Trabodenoson (Drug)
Trabodenoson Plus Latanoprost
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
干预措施: Latanoprost (Drug)
Timolol Plus Latanoprost
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
干预措施: Latanoprost (Drug)
Timolol Plus Latanoprost
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
干预措施: Timolol (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 12 weeks
次要结局
未报告次要终点