Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Inflammation
研究概览
简要总结
Inflammation occurs after any type of incisional surgery. This study will evaluate the efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative inflammation after routine eyelid surgery.
详细描述
Eyelid surgery such as blepharoplasty is often performed for functional and cosmetic indications. Following any incisional surgery, postoperative inflammation occurs at the surgical site. This study will evaluate the efficacy of reducing postoperative inflammation after bilateral eyelid surgery using Loteprednol etabonate (steroid) vs. Soothe ointment (vehicle of Loteprednol etabonate). Common postoperative changes at the incision include: erythema, thickening/elevation of the skin, pigmentary changes and pain. The use of a topically applied steroid would be expected to reduce inflammation and this study will evaluate this. For each patient, one eyelid will be randomly chosen to treat with medication and the other eyelid will be treated with vehicle ointment and by using the same patient, each patient will be internally controlled. Antibiotic prophylaxis is often given after eyelid surgery and this will be used in all patients in the study.
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)
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
- •Age > 18 years old
- •Scheduled for bilateral eyelid surgery
- •Willing and able to return for all study visits
- •Willing and able to administer treatments as required
- •Understand and sign informed consent approved by UCSD institutional review board
排除标准
- •History of allergy to investigational drug (Loteprednol etabonate) or ingredient in drug including petrolatum
- •History of collagen vascular disease and receiving concurrent treatment that could interfere with interpretation of study results
- •Concurrent ocular therapy with nonsteroidal anti-inflammatory drugs, mast cell stabilizers, antihistamines, decongestants, immunosuppresants, and systemic or ocular corticosteroids
- •History of immunodeficiency
- •Prior eyelid or facial surgery
- •Prior ocular or orbital trauma
- •History of ocular hypertension, steroid responder, or glaucoma
- •Pregnancy or lactation
- •Uncontrolled systemic disease or significant illness
- •Any other condition the investigator believe would pose a significant hazard to the subject if the investigational therapy were initiated
研究组 & 干预措施
Loteprednol etabonate ointment
This is the arm which contains loteprednol steroid
干预措施: Loteprednol etabonate ophthalmic ointment (Drug)
Vehicle Ointment
This arm contains vehicle only.
干预措施: Vehicle Ophthalmic Ointment (Drug)
结局指标
主要结局
Inflammation
时间窗: 24 weeks after surgery
Inflammatory changes of the periocular skin will be assessed by several criteria including: 1. Erythema 2. Wound elevation 3. Pigmentary changes 4. Exudate 5. Excoriation 6. Crusting 7. Scaling 8. Pain 9. Itching
次要结局
未报告次要终点
研究者
Bobby Korn, MD, PhD
Associate Professor of Ophthalmology
University of California, San Diego