Intracanalicular Dexamethasone Used in Conjunction With ILUX for the Treatment of Meibomian Gland Dysfunction (MGD) in Patients With Evaporative Dry Eye 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
- 30
- 试验地点
- 1
- 主要终点
- Change in Meibomian gland score (MGS)
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 iLUX MGD Treatment System.
详细描述
This prospective study will use a fellow-eye design for 30 participants, (2 groups of 15) equating to 60 eyes. All eyes will receive bilateral iLUX MGD Treatment System. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye). In group 1, the other eye will be assigned to receive prednisolone acetate 1% on a 4,3,2,1 month taper schedule (active comparator). In group 2, the other eye will receive punctal "sham" dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 30 eyes receiving DEXTENZA® insertion. The control group will consist of 15 eyes receiving prednisolone acetate 1% and 15 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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:
- •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
Group 2: Sham dilation
15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye).
干预措施: Control (Other)
Dexamethosone intracanalicular insert
All 30 eyes will undergo iLUX MGD Treatment System for the treatment of evaporative DED secondary to MGD. Patients will have their most symptomatic eye selected to receive the dexamethasone intracanalicular insert at the day of the iLUX MGD Treatment System (study eye).
干预措施: Dexamethasone, 0.4mg (Drug)
Group 1: Prednisolone actetate 1%
15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days.
干预措施: Prednisone acetate (Drug)
结局指标
主要结局
Change in Meibomian gland score (MGS)
时间窗: Assessed on week 1, week 4 and week 12.
Change from baseline in meibomian gland scores (expressibility and quality)
Patient satisfaction with treatment
时间窗: Assessed on week 12
preference for therapy as measured by COMTOL
次要结局
- Change in Matrix metalloproteinase (MMP) -9(Assessed on Week 1, 4, 12)
- Change in tear osmolarity(Assessed on week 1, week 4 and week 12)
- Change in Ocular Surface Disease Index (OSDI) score(Assessed on week 1, week 4 and week 12)
- Change in corneal staining(Assessed on week 1, week 4 and week 12)
- Change in best corrected visual acuity(Assessed on week 1, week 4 and week 12)
- Physician Ease of Insertion of Dextenza(Assessed on day 1)