Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mean change in ocular surface staining
研究概览
简要总结
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
详细描述
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 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
- 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
- •Signs and symptoms of DED
- •Consent to treat with topical immunomodulator
- •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
- •Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
- •Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
Xiidra Only Group
Patients with dry eye disease Xiidra only
干预措施: Lifitegrast 5% Ophthalmic Solution (Drug)
Xiidra + Dextenza Group
Patients with dry eye disease Xiidra + Dextenza
干预措施: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution (Drug)
结局指标
主要结局
Mean change in ocular surface staining
时间窗: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
As measured by sodium fluorescein and lissamine green
Patient Preference for therapy
时间窗: Assessed at Week 12 Visit
As measured by COMTOL Survey
次要结局
- Mean change in conjunctival injection(Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit)
- Change from baseline in meibomian gland scores (expressibility and quality)(Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit)
- Mean change in DEQ-5(Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit)
- Mean change in Best-corrected Visual Acuity (BCVA)(Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit)
- Mean change in MMP-9(Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit)
- Mean change in tear osmolarity(Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit)
- Mean change in tear break-up time (TBUT)(Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit)