NCT03952481撤回4 期
Improvement in Markers of Tear Film Instability After Initiation of Lifitegrast 5% Ophthalmic Solution: A Prospective Interventional Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The change in proportion of subjects demonstrating improved tear film osmolarity
研究概览
简要总结
The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Signs or symptoms of Dry Eye Disease
- •18 years or older
- •Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference >=8 mOsm/mL)
排除标准
- •Active eye infection. Patients with blepharitis may be enrolled.
- •Any eye drop that was instilled within 2 hours of the Baseline eye exam
- •Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll.
- •History of ocular herpes simplex
- •Active episcleritis, scleritis, iritis or uveitis
- •Active keratitis secondary to any etiology other than dry eyes
- •History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK)
- •Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes
- •Active allergic conjunctivitis
- •Current use of punctal plugs or anticipation of use during the study
- •Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study
- •Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit.
- •Allergy to lifitegrast 5%
研究组 & 干预措施
Lifitegrast 5% Ophthalmic Solution
Experimental
Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.
干预措施: Lifitegrast 5% Ophthalmic Solution (Drug)
结局指标
主要结局
The change in proportion of subjects demonstrating improved tear film osmolarity
时间窗: Baseline, Weeks 1, 2, 3 and 4
Improved tear film osmolarity will be defined as an osmolarity reading of less than or equal to 308 mOsm/L or an inter-eye difference osmolarity reading of less than or equal to 8 mOsm/L.
次要结局
- The proportion of subjects demonstrating normal Matrix Metallopeptidase 9 (MMP9).(Week 4)
- The proportion of subjects demonstrating normal Tear Break-Up Time (TBUT).(Week 4)
- The proportion of subjects demonstrating normal corneal fluorescein staining.(Week 4)
- The proportion of subjects demonstrating improvement in their symptoms as measured by the modified SANDE Questionnaire.(Week 4)
研究者
研究点 (1)
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