A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in corneal fluorescein staining
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.
详细描述
This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate Keratoconjunctivitis Sicca.
- •A corrected visual acuity in both eyes of 20/40 or better.
- •An intraocular pressure of < 21 mm Hg with a difference between eyes of < 6 mm Hg.
排除标准
- •History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.
- •History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.
- •History of herpes simplex keratitis at any time.
- •Current ocular allergy symptoms.
- •Recent use of eye medications such as steroids or cyclosporine
- •Refractive eye surgery within 12 months of the first dosing day.
- •Other eye surgeries within 4 months of the first dosing day.
- •Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
- •Receipt of any blood or blood products within 90 days prior to the first dosing day.
- •Participation in any clinical study within 30 days prior to the first dosing day.
- •History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.
- •Positive for hepatitis B, hepatitis C or HIV.
- •Smoked regularly within 12 months of first dosing day.
- •History of substance abuse, drug addiction or alcoholism.
研究组 & 干预措施
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
干预措施: R348 Ophthalmic Solution, 0.2% (Drug)
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
干预措施: Placebo (Drug)
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
干预措施: R348 Ophthalmic Solution, 0.5% (Drug)
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
干预措施: Placebo (Drug)
R348 Ophthalmic Solution, 1.0%
R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
干预措施: R348 Ophthalmic Solution, 1.0% (Drug)
R348 Ophthalmic Solution, 1.0%
R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
干预措施: Placebo (Drug)
Placebo
Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in corneal fluorescein staining
时间窗: Baseline and Visits 4, 8 and 12
次要结局
- Change in conjunctival lissamine green staining(Baseline and Visits 4, 8 and 12)