Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine effect of dexamethasone insert over artificial tears
研究概览
简要总结
To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management
详细描述
This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures.
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
- 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
- 是
入选标准
- •A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- •Age 18 years and older
- •Demonstrate objective signs of Ocular Surface Disease (OSD) or
- •Demonstrate symptoms of OSD determined by a standardized questionnaire
- •No other corneal pathology to create unknown variability
排除标准
- •A patient who meets any of the following criteria in either eye will be excluded from the study:
- •History of using topical steroids or other anti-inflammatory drops within 6 months of the study
- •History of corticosteroid implant (Ozurdex or Iluvien) or intravitreal steroid use for macular disease in last 12 months
- •History or current use of oral steroids or immunosuppressants
- •Active ocular infection
- •History of HSV
- •History corneal refractive surgery
- •Uncontrolled Glaucoma
研究组 & 干预措施
Dextenza
Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed
干预措施: Dextenza 0.4Mg Intracanalicular Insert (Drug)
Over the counter Artificial tears
Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert
干预措施: Over the counter Artificial tears (Other)
结局指标
主要结局
Determine effect of dexamethasone insert over artificial tears
时间窗: 1 month
To determine the effect of dexamethasone insert plus over-the-counter artificial tears prn compared to over the counter artificial tears prn from Baseline at Week 2 (at 8 am, 12 pm and 4 pm) as measured by iTrace and IOL Master 700: and comfort of dry eyes using the OSDI scale and reading scores
次要结局
- OSDI scores(1 month)
研究者
Inder Paul Singh, M.D.
I. Paul Singh, M.D. Principal Investigator
The Eye Centers of Racine and Kenosha