NCT04693429已完成1 期
Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of 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
- 22
- 试验地点
- 1
- 主要终点
- Incidence of Related Unexpected Adverse Events (AE)
研究概览
简要总结
Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy volunteers
- •Being capable of voluntarily grant a signed informed consent.
- •Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
- •Being between 18 and 45 years old.
- •Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method of intrauterine device (IUD) during the study.
- •Having a best corrected visual acuity equal or better than 20/30 in both eyes.
- •Showing normal vital signs.
- •Having an intraocular pressure between 10 and 21 mmHg.
排除标准
- •Using any kind of ophthalmic topical product.
- •Using drugs or herbal products, through any administration route.
- •For women: pregnancy, breastfeeding or planning to become pregnant during the time of the study.
- •Having participated in clinical trials 90 days prior to inclusion in this study.
- •Having participated previously in this study.
- •Using contact lenses and not being able to suspend such use during the period of the study.
- •Being unable to follow the lifestyle modification considerations required for the study.
- •Having started the use of hormonal contraceptives of IUD within 30 days previous of inclusion in this study.
- •Suffering any chronic degenerative diseases.
- •Suffering active inflammatory of infectious disease when entering this study.
- •Suffering unresolved lesions or traumas when entering this study.
- •Having a previous history of any kind of ocular surgery.
- •Having a previous history of any surgical procedure, non ophthalmological, within the last 3 months.
研究组 & 干预措施
PRO-172
Experimental
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
干预措施: Bepotastine Besilate (Drug)
结局指标
主要结局
Incidence of Related Unexpected Adverse Events (AE)
时间窗: Day 10
Presence/absence of related non expected adverse events
Ocular Comfort Index
时间窗: Day 8
Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
次要结局
- Changes in Best Corrected Visual Acuity (BCVA)(Baseline vs Day 8)
- Conjunctival and Corneal Staining With Lissamine Green(Day 8)
- Conjunctival Hyperemia(Day 8)
- Conjunctival and Corneal Staining With Fluorescein(Day 8)
- Chemosis Incidence(Day 8)
研究者
研究点 (1)
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