Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 44
- 主要终点
- Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
研究概览
简要总结
This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Parallel-Group Phase:
- •Weigh at least 110 lbs
- •18 to 45 years old
- •Paired-Eye Phase:
- •Dry eye disease in both eyes
排除标准
- •Parallel-Group Phase:
- •Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
- •Has donated blood within 90 days
- •Significant weight change (over 10 lbs) within 60 days
- •Previous use of RESTASIS®
- •Parallel-Group and Paired-Eye Phases:
- •Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
- •Consumption of alcohol products within 72 hours
- •Paired-Eye Phase:
- •Previous ocular surgery
- •Use of RESTASIS® within 30 days
研究组 & 干预措施
Formulation B and cyclosporine ophthalmic emulsion 0.05%
PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
干预措施: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% (Drug)
cyclosporine ophthalmic emulsion Formulation A (Formulation A)
Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
干预措施: cyclosporine ophthalmic emulsion Formulation A (Drug)
cyclosporine ophthalmic emulsion Formulation B (Formulation B)
PGP: cyclosporine ophthalmic emulsion Formulation B
干预措施: cyclosporine ophthalmic emulsion Formulation B (Drug)
Formulation A and cyclosporine ophthalmic emulsion 0.05%
Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
干预措施: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% (Drug)
Formulation A and Formulation B
PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
干预措施: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B (Drug)
结局指标
主要结局
Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
时间窗: Day 1
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
次要结局
- Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)(3 Days)
- Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1(Day 1)