A Randomized, Parallel-Group, Multi-Center, Investigator-Masked, Active-and Placebo-Controlled, Phase 1-2 Evaluation of the Safety and Efficacy of OT-730 Ophthalmic Solution in Reducing the Intraocular Pressure in Subjects With Ocular Hypertension or Open-Angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Assess the safety profile of OT-730
研究概览
简要总结
The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.
详细描述
Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents, which can have undesirable side effects on the cardiac and respiratory systems.
The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop, metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or ocular hypertension. It will be compared with a well known beta blocker, timolol maleate ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP without the typical side effects of other beta blockers.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •healthy subjects, 18 to 80 years of age, any gender
- •diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension
排除标准
- •have VA worse than 20/200,
- •cataract that compromises visualization of fundus,
- •history of lack of response to ocular beta blocker therapy,
- •uncontrolled intraocular pressure,
- •angle closure glaucoma or occludable angles,
- •retinal detachment, macular hole, progressive vision loss, any progressive retinal disease or neurologic disease other than glaucoma that is likely to worsen visual field or acuity during the course of the study,
- •a history of, or any current condition contraindicated with use of a beta blocker (e.g., chronic obstructive pulmonary disease, bronchial asthma, congestive heart failure, myasthenia gravis, hypoglycemia, bradycardia, etc),
- •chronic use of steroids,
- •any disease that, in the opinion of the investigator, may put the patient at significant risk,
- •taking systemic beta blockers
研究组 & 干预措施
1
OT-730 ophthalmic solution
干预措施: OT-730 ophthalmic solution (Drug)
2
timolol maleate ophthalmic solution
干预措施: timolol maleate ophthalmic solution (Drug)
3
placebo eye drops
干预措施: OT-730 placebo (Drug)
结局指标
主要结局
Assess the safety profile of OT-730
时间窗: 8 days
Change from baseline in intraocular pressure
时间窗: Day 6
次要结局
未报告次要终点