A Phase 1/2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Healthy Volunteers and Patients With Pterygium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 12
- 主要终点
- Change from baseline in pterygium hyperemia grading at Day 28
研究概览
简要总结
The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.
详细描述
Following informed consent, patients with pterygium who meet all eligibility criteria will be randomized to an 84-day double-blinded study to measure the safety and efficacy of the study drug as compared to placebo.
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)
盲法说明
Sponsor/CRO clinical operations team will also be masked. Sponsor/CRO biostats team and drug supply manager will be unmasked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years old
- •Diagnosis of pterygium with specified characteristics
- •BCVA of 20/200 or better
- •Willingness to attend all study visits and comply with the study procedures
排除标准
- •Presence of ocular disease
- •Double pterygium
- •History of ocular surgery
- •Presence of ocular trauma
- •Use of any ocular medication
- •Use of contact lens
- •Allergy to any of the components of study drug
- •Cannot properly administer study drug
- •Clinically significant systemic disease that may place the subject at risk or confound study results
- •Participation in an investigational study within 30 days prior to screening
- •Female participants who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control (WOCBP).
研究组 & 干预措施
Patients randomized to placebo
Approximately 25 patients randomized to placebo.
干预措施: RMP-A03 Placebo (Drug)
Patients randomized to dose 1 study drug
Approximately 25 patients randomized to dose 1 of RMP-A03
干预措施: RMP-A03 - Dose 1 (Drug)
Patients randomized to dose 2 of study drug
Approximately 25 patients randomized to dose 2 of RMP-A03
干预措施: RMP-A03 - Dose 2 (Drug)
结局指标
主要结局
Change from baseline in pterygium hyperemia grading at Day 28
时间窗: 28 days
Pterygium hyperemia grading will be assessed by the principal investigator based on predefined vascularity scale.
次要结局
- Change from baseline in pterygium characteristics at Day 28(28 days)