Randomized, Double-Masked, Placebo-Controlled Multiple-Dose Phase 1 Study to Evaluate the Safety and Tolerability of Different Doses of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 90
- 主要终点
- Number of Subjects With Dose-limiting Adverse Events
研究概览
简要总结
Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic solution compared to placebo in healthy subjects
详细描述
The primary objective of the study is to establish the ocular safety and tolerability, and systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects. Safety and tolerability will be compared to those of a placebo.The PHMB bioavailability in plasma will also be assessed
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able and willing to give informed consent.
- •man or woman of any race and 18 to 55 years of age, inclusive.
- •Body Mass Index of 20-30 kg/m2
- •willing and able to attend required study visits.
- •bilateral visual acuity >6/
- •intraocular pressure (IOP) of 14-21 mmHg.
- •ophthalmologic examination without abnormalities.
- •medical history without major pathology.
- •laboratory test results without deviations from the normal range.
- •female subjects of childbearing potential with negative urine pregnancy test and using effective contraception during the study.
排除标准
- •presence of bacterial ocular infections.
- •presence of any concomitant ocular pathology.
- •performing activities likely to result in an irritated conjunctiva during the study (including heavy alcohol intake, swimming in chlorinated water and heavy smoking).
- •contact lenses wearing .
- •ocular surface fluorescein staining score >
- •use of topical or systemic antibiotics, antihistamines, decongestants and non-steroidal anti-inflammatory agents as well as steroids within 7 days before screening.
- •known or suspected allergy to biguanides or intolerance to any other ingredient of the test treatments.
- •ocular surgery performed within 12 months before screening.
- •participation in another clinical study in the preceding 30 days.
- •one functional eye.
- •pregnancy or breastfeeding.
- •use of recreational drugs.
研究组 & 干预措施
0.04% PHMB
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
干预措施: 0.04% PHMB (Drug)
0.06% PHMB
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
干预措施: 0.06% PHMB (Drug)
0.08% PHMB
0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
干预措施: 0.08% PHMB (Drug)
PHMB Vehicle
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
干预措施: PHMB Vehicle (Drug)
结局指标
主要结局
Number of Subjects With Dose-limiting Adverse Events
时间窗: up to 21 days from date of randomization
次要结局
- Plasma Concentration of PHMB(Day14)