NCT04527887终止4 期
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in ocular inflammation
研究概览
简要总结
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.
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)
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
- •Diagnosis of Dry Eye Disease
- •Objective Signs (Schirmer's II test <10 mm at 5 min; Tear Break-Up time (TBUT) of <10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive >=4 in at least 1 eye)
- •Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy
排除标准
- •History of Diabetes
- •History of ocular surgery, corneal infection, or corneal injury within the last 3 months
- •Active ocular allergies
- •Active ocular infection
- •Allergic to benzalkonium chloride
研究组 & 干预措施
Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)
Active Comparator
intracanalicular dexamethasone insert
干预措施: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) (Drug)
ProLong™ collagen plugs
Placebo Comparator
collagen plug
干预措施: ProLong™ collagen plugs (Other)
结局指标
主要结局
Change in ocular inflammation
时间窗: Change from Baseline one month after intracanalicular insert implantation or punctal plug
As measured by change to dendritic cell density and ocular redness
次要结局
- Clinical Parameter: Ocular Surface Disease Index (OSDI)(Change from Baseline one month after intracanalicular insert implantation or punctal plug)
- Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)(Change from Baseline one month after intracanalicular insert implantation or punctal plug)
- Clinical Parameter: Ocular Pain Assessment Survey (OPAS)(Change from Baseline one month after intracanalicular insert implantation or punctal plug)
- Clinical Parameter: Conjunctival staining(Change from Baseline one month after intracanalicular insert implantation or punctal plug)
- Clinical Parameter: Tear Break Up Time (TBUT)(Change from Baseline one month after intracanalicular insert implantation or punctal plug)
- Clinical Parameter: Corneal staining with fluorescein(Change from Baseline one month after intracanalicular insert implantation or punctal plug)
- Clinical Parameter: Schirmer II test(Change from Baseline one month after intracanalicular insert implantation or punctal plug)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or LotemaxDry EyeNCT04555694Thomas Chester, OD30
终止
4 期
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye DiseaseDry Eye SyndromesNCT04413253Eye Surgeons of Indiana5
已完成
4 期
Dextenza With ILUX for Treatment of MGDEvaporative Dry EyeMeibomian Gland DysfunctionNCT04658927Warrenville Eyecare30
已完成
4 期
Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye DiseaseDry Eye SyndromesNCT04413279Eye Surgeons of Indiana20
已完成
4 期
The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective StudyRefractive SurgeryNCT04396990Vance Thompson Vision20