Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 8
- 主要终点
- Safety of new drug
研究概览
简要总结
This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 15 centers in the United States (US).
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
- Double (Participant, Investigator)
盲法说明
Treatment assignment will be unknown (or masked) to the study subjects, the evaluating physician, the Sponsor and its agents (with the exception of personnel performing randomization, unmasked drug accountability study monitors, and corporate compliance staff). The treating physician 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
- 是
入选标准
- •Capable of giving informed consent
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
排除标准
- •Current or past diagnosis of endophthalmitis
- •Current diagnosis of uveitis
- •Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
- •Current use of viscous lidocaine products for ocular anesthesia prior to IVT
- •Currently receiving intravitreal steroid injections
- •Concurrent participation in another clinical trial
- •Females who are pregnant, planning to become pregnant or lactating
研究组 & 干预措施
IRX-101
Subjects randomized to IRX-101 will receive the investigational product, IRX-101.
干预措施: IRX-101 (Drug)
5% Povidone-iodine
Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.
干预措施: Providone-Iodine (Drug)
结局指标
主要结局
Safety of new drug
时间窗: 1-hour and 1-week post-treatment
Safety will be measured via slit lamp and fundoscopic examinations
次要结局
- Patient-reported post-injection pain scores(1-hour post-administration)
- Mean corneal fluorescein staining scores(Immediately following intraviteral injection)