NCT01535443已完成1 期
Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
详细描述
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •Healthy male and female.
- •Age ≥ 18 years old at screening visit
排除标准
- •Any ocular or systemic condition.
- •Patient with one blind eye.
- •Visual acuity of 20/40 in any eye.
- •Use of ocular or systemic medications.
- •Contraindications or sensitivity to any component of the study treatments.
- •Contact lens users.
- •Ocular surgery within the past 3 months..
- •Women who were not using an effective means of contraception or who were pregnant or nursing.
- •Participation in any studies of investigational drugs within 90 days previous to the inclusion.
研究组 & 干预措施
Bromfenac
Experimental
Drug: Bromfenac ophthalmic solution 1 drop 4 times per day
干预措施: Bromfenac (Drug)
结局指标
主要结局
Visual Acuity
时间窗: 10 days
A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst
次要结局
- Findings in Posterior Segment(10 days)
- Intraocular Pressure (IOP)(10 days)
- Hyperemia(10 days)
- Chemosis(10 days)
- Corneal Damage by Fluorescein Staining Test(10 days)
- Corneal Damage by Lissamine Green Staining Test(10 days)
- Burning(10 days)
- Tearing(10 days)
- Foreign Body Sensation(10 days)
- Photophobia(10 days)
- Adverse Events(10 days)
研究者
研究点 (1)
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