Phase I Clinical Trial to Assess the Safety and Tolerability of the Ophthalmic Solution PRO-156 Over the Ocular Surface of Ophthalmologically Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Visual Acuity (VA)
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers
详细描述
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female.
- •Age between 18 and 40 years old at screening visit.
- •Signed informed consent
排除标准
- •Patient with one blind eye.
- •Any ocular or systemic condition.
- •Visual acuity of 20/100 in any eye.
- •Use of ocular or systemic medication.
- •Contraindications or sensitivity to any component of the study treatment.
- •Contact lens users.
- •Ocular surgery within the past 3 months..
- •Pregnant, nursing or childbearing potential women who were not using effective contraception.
- •Participation in any studies of investigational drugs within 90 days previous to the inclusion.
研究组 & 干预措施
PRO-156
Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
干预措施: PRO-156 (Drug)
结局指标
主要结局
Visual Acuity (VA)
时间窗: 11 days
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5
次要结局
- Number of Cases With Adverse Events(11 days)
- Intraocular Pressure (IOP)(11 days)
- Number of Eyes With Epithelial Defects(11 days)