Safety and Efficacy of Lifitegrast 5% Ophthalmic Solution in Contact Lens Discomfort
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in CLDEQ-8 scores as reported by study participants
研究概览
简要总结
The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.
详细描述
Contact lens discontinuation is mostly associated with ocular discomfort. Most patients identifying dryness as the primary reason for contact lens discontinuation. Patients often resort to contact lens solutions, lubricating and/or rewetting drops to temporality improve their contact lens wearing experience. Clinicians often resort to changing contact lens designs, solutions and wearing modalities to improve comfort.
Contact lens discomfort is believed to be mediated by many factors including inflammation and very similar in clinical symptoms of dry eye disease and symptoms of dryness.
Lifitegrast 5.0% ophthalmic solution is an FDA approved solution for the management of signs and symptoms of dryness of dry eye disease. Studies have shown lifitegrast 5% ophthalmic solution may work by blocking the interaction between ICAM-1 and LFA-1 leading to a decrease in activation and recruitment of T-cells, an initial step in inflammation.
The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients for signs (https://www.xiidra-ecp.com/efficacy-treating-signs) and symptoms (https://www.xiidra-ecp.com/efficacy-symptom-improvement).
The purpose of this open label, interventional study is to examine the effect of lifitegrast 5% ophthalmic solution in contact lens wearing experience by using the CLDEQ-8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agree with study protocol
- •Provide Informed Consent
- •Age 21 or over
- •Previous 10 months history of self-assessed comfortable wear samfilcon A contact lenses
排除标准
- •Unable or unwilling to comply with study protocol
- •Unable of unwilling to provide Informed consent
- •Self-reported symptomatic intolerance of contact lenses
- •History of an active anterior segment, eyelids, eyelashes, corneal or conjunctival pathology, ongoing ocular infection, inflammation or any other ocular problem that would require management with additional topical ophthalmic medications.
- •Have had a history of corneal surgery (corneal transplants, LASIK, PRK).
研究组 & 干预措施
Intervention Group
Lifitegrast 5% ophthalmic solution group
干预措施: Lifitegrast (Drug)
结局指标
主要结局
Change in CLDEQ-8 scores as reported by study participants
时间窗: baseline to week 8
measured changes in CLDEQ-8 scores as reported by study participants
Lisamine (corneal, conjunctiva) staining scores
时间窗: baseline to week 8
Lisamine score using the Oxford-Schema scoring
次要结局
- Visual Acuity(Baseline to week 8)
研究者
Agustin Gonzalez
Principal Investigator
EV Clinical Trials