Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient preference for
研究概览
简要总结
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.
详细描述
This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy.
After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- •18 years of age or older
- •Evaporative DED with MGD and clinically significant inflammation
- •Willing and able to comply with clinic visits and study related procedures
- •Willing and able to sign the informed consent form
排除标准
- •A patient who meets any of the following criteria will be excluded from the study:
- •Patients under the age of
- •Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- •Active infectious systemic disease
- •Active infectious ocular or extraocular disease
- •Altered nasolacrimal flow of either acquired, induced, or congenital origin
- •Hypersensitivity to dexamethasone
- •Patient being treated with either topical, oral, or intravenous steroids
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
Lipiflow Only Group
Patients with dry eye disease Lipiflow only
干预措施: LipiFlow Thermal Pulsation (Procedure)
Lipiflow + Dextenza Group
Patients with dry eye disease Lipiflow + Dextenza
干预措施: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation (Drug)
结局指标
主要结局
Patient preference for
时间窗: Assessed at Week 12
As measured by COMTOL Survey
Change from baseline in meibomian gland scores (expressibility and quality)
时间窗: Assessed at Baseline, Week 1, Week 4 and Week 12
As measured on a grading scale 1 to 4 and graded by the physician
次要结局
- Mean change in tear break-up time (TBUT)(Assessed at Baseline, Week 1, Week 4 and Week 12 Visit)
- Mean change in MMP-9(Assessed at Baseline, Week 1, Week 4 and Week 12 Visit)
- Mean change in ocular surface staining(Assessed at Baseline, Week 1, Week 4 and Week 12 Visit)
- Mean change in tear osmolarity(Assessed at Baseline, Week 1, Week 4 and Week 12 Visit)
- Mean change in DEQ-5(Assessed at Baseline, Week 1, Week 4 and Week 12 Visit)
- Mean change in Best-corrected Visual Acuity (BCVA)(Assessed at Baseline, Week 1, Week 4 and Week 12 Visit)