Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Conjunctival bulbar hyperemia
研究概览
简要总结
Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.
详细描述
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-143 ophthalmic solution 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 systemics 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
PRO-143 Ophthalmic Solution
PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.
干预措施: PRO-143 Ophthalmic Solution (Drug)
结局指标
主要结局
Conjunctival bulbar hyperemia
时间窗: 10 days
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
Number of Participants with adverse events
时间窗: 10 days
he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis
次要结局
- Intraocular pressure (IOP)(10 days)
- Visual ability (VA)(10 days)
- Eye comfort index (ICO)(10 days)