Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Visual Analog Scale Pain Score
研究概览
简要总结
The goal of this clinical trial is to learn how various topical drops (bromfenac, loteprednol, and artificial tears) fare in alleviating post-intravitreal injection pain. The main questions it aims to answer are:
- Do bromfenac sodium and/or loteprednol etabonate improve post-injection pain scores compared to preservative-free artificial tears?
Participants will:
- Receive one drop of the topical drops five minutes prior to their regularly scheduled intravitreal injection. Depending on the treatment arm, they will also administer drops on their own at home up to 3 times per day on the day of their procedure.
- They will answer a standardized pain score survey at 4 hours and 24 hours following their intravitreal injection and convey their results to study coordinators by phone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Standard of Care Treatment with intravitreal injection
- •History of at least 1 anti-VEGF injection in the 90 days prior to inclusion
- •Less than 13 intravitreal injection in the 365 days prior to inclusion
排除标准
- •History of autoimmune disease, graft versus host disease, neurotrophic corneal disease, contact lens use, keratitis, fibromyalgia, uveitis, herpetic ocular disease
- •Drug allergy to any drug components
- •History of any ocular surgery in the 30 days prior to inclusion
- •Current topical corticosteroid or non-steroidal anti-inflammatory drug (NSAID)
研究组 & 干预措施
Bromfenac
Bromfenac sodium 0.07% is a nonsteroidal anti-inflammatory drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection.
干预措施: Bromfenac Sodium 0.07% (Drug)
Loteprednol
Loteprednol etabonate ophthalmic gel 0.38% is a steroidal drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection.
干预措施: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly (Drug)
Artificial Tears
Propylene Glycol Preservative-free artificial tears is a placebo comparator to be adminstered in the eye receiving the standard of care intravitreal injection.
干预措施: Propylene Glycol Preservative-free Artificial Tears (Drug)
结局指标
主要结局
Visual Analog Scale Pain Score
时间窗: At 4 hours and 24 hours following intravitreal injection
A standardized Visual Analog Scale (VAS) pain score is collected at 4 hours and 24 hours following standard of care intravitreal injection. Patients are provided a VAS scale and receive a call from study coordinators to collect pain scores.
次要结局
未报告次要终点