Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary: Tear osmolarity
研究概览
简要总结
To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months.
详细描述
A longitudinal, single-arm, prospective study will recruit up to 30 subjects with moderate to severe dry eye disease. Subjects will be >18 years of age, diagnosed with moderate to severe dry eye (tear osmolarity > 320 mOsm/L and Visual Analog Scale (VAS) score > 40), willing to adhere to twice daily dosing (BID) and follow up visit schedule, have no history of ocular pathology / degeneration / allergy, not on any T-cell modulatory therapy, not have instilled any artificial tears within 2 hours of study visit, and not participating in any concurrent clinical trials. All subjects will complete an informed consent form indicating their voluntary participation in the study.
Study measurements will be made at baseline (first clinic visit), 2-, 6-, and 12-weeks following Lifitegrast therapy and include tear osmolarity (TearLab osmolarity system), VAS questionnaire, slit lamp examination for fluorescein corneal staining, tear break up time (TBUT), and Meibomian gland dysfunction (MGD) grading . At the end of the 3-mo study visit, the subjects will be informed of study completion and exited from the study.
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
- 否
入选标准
- •Tear Osmolarity > 320 mOsm/L
- •VAS eye dryness > 40
- •No other ocular pathology
- •No contact lens wear
- •Not currently on T cell modulator
- •No change in therapy in last 2 months
- •Willingness to adhere to therapy and study visits
- •Patients qualified for prescription of lifitegrast drops
排除标准
- •Contact lens use
- •Eye surgery in Past 6 months
- •Use of tear supplements in past 2 hours
研究组 & 干预措施
Mild Dry Eye Cohort
Prospective 3 month study of subjects with Tear Osmolarity >308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
干预措施: Lifitegrast (Drug)
Moderate to Severe Dry Eye Cohort
Prospective 3 month study of subjects with Tear Osmolarity >320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID.
干预措施: Lifitegrast (Drug)
结局指标
主要结局
Primary: Tear osmolarity
时间窗: Baseline to the study completion, up to 3 months.
Number of participants with an improvement in Tear Osmolarity measured using the Tear Osmolarity score treated with Lifitegrast.
次要结局
- VAS(VAS dry eye questionnaire, tear break up time and meibomian gland grading will be serially measured over 3 months during treatment with Lifitegrast gtts)
- Corneal Staining Grade(Baseline to the study completion, up to 3 months.)
- TBUT(Baseline to the study completion, up to 3 months.)
- MGD grade(Baseline to the study completion, up to 3 months.)