Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change from baseline to week 12 in corneal fluorescein staining score
研究概览
简要总结
To evaluate glaucoma patients' response to treatment with Xiidra, an FDA-approved drug for ocular surface discomfort, which will be prescribed as standard of care treatment.
详细描述
To assess glaucoma patients' response to treatment with Xiidra (Lifitegrast ophthalmic solution) 5% for ocular surface discomfort caused, in part, by topical glaucoma antihypertensive medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently using one or more topical glaucoma antihypertensives
- •Self-described symptoms of ocular surface discomfort
- •Xiidra is being prescribed as part of the subject's standard care
排除标准
- •History of glaucoma filtration surgery, history of ocular surface surgery (pterygium, conjunctivoplasty, etc.),
- •current use of topical cyclosporine
- •current use of topical steroids
- •incisional ocular surgery within 6 months
研究组 & 干预措施
Group 1
Xiidra (Lifitegrast ophthalmic solution) 5% applied to both eye (OU) for 12 weeks
干预措施: Xiidra (Lifitegrast ophthalmic solution) 5% (Drug)
结局指标
主要结局
Change from baseline to week 12 in corneal fluorescein staining score
时间窗: From baseline to Week 12
Change in corneal fluorescein staining score
Change from baseline to week 12 in eye dryness score (EDS)
时间窗: From baseline to Week 12
Change in eye dryness score (EDS)
Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score
时间窗: From baseline to Week 12
Change in ocular surface disease index (OSDI) questionnaire score
次要结局
- Change at intermediate week visits in corneal fluorescein staining score(From baseline and at weeks 2, 6, and 12)
- Change at intermediate week visits in eye dryness score (EDS)(From baseline and at weeks 2, 6, and 12)
- Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score(From baseline and at weeks 2, 6, and 12)
- Changes in the subcategories of ocular surface disease index (OSDI) questionnaire score at intermediate week visits(From baseline and at weeks 2, 6, and 12)
研究者
Benjamin B. Bert, MD
Health Sciences Assistant Professor
University of California, Los Angeles