NCT04297618已完成4 期
The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline
研究概览
简要总结
The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Is at least 18 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Currently wears daily, soft, frequent replacement lenses (daily, bi-weekly or monthly disposable lenses) in both eyes, that are available in Canada, for a minimum of 5 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study;
- •Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at the end of the wear day AND according to the classification by Young et al7;
- •Can achieve acceptable lens fit as well as visual acuity (VA) correctable to logMAR +0.20 or better in each eye with their habitual contact lens type;
- •Has a history of artificial tear or rewetting drop use at least once in the last 30 days;
- •Is willing to use the Xiidra study drops twice a day on a daily basis (irrespective of CL wear) and to stop use of any habitual rewetting drops and/or artificial tears over the course of the 12-week treatment phase;
排除标准
- •Is participating in any concurrent clinical or research study;
- •Is wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer;
- •Has a known sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study;
- •Has any known ocular disease and/or infection, that's either currently active* or has occurred within the previous 30 days;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (examples may include active or uncontrolled systemic conditions such as allergies, autoimmune disease or immunodeficiency disease);
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable, including but not limited to topical cyclosporine, any other topical ophthalmic medication, antihistamines, and aspirin;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);**
- •Has undergone refractive error surgery such as LASIK within the last 12 months;
- •Has a history of yttrium-aluminium-garnet laser posterior capsulotomy within the previous 6 months,
- •Is an employee of the Centre for Ocular Research & Education; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
研究组 & 干预措施
Xiidra treatment
Experimental
Each participant will use the same study drops, Xiidra, over the course of the 12-week study.
干预措施: Xiidra (Drug)
结局指标
主要结局
Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline
时间窗: Baseline and 12 weeks
Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).
Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline
时间窗: Baseline and 12 weeks
Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Efficacy of Xiidra in Dry Eye Disease After Collagen Cross LinkingCorneal DiseaseNCT05045053Benha University40
招募中
不适用
Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical MedicationsGlaucomaOcular Surface DiseaseNCT04354545University of California, Los Angeles75
撤回
4 期
Ocular Inflammation in Cataract Patients and Response to Treatment With XiidraDry EyeNCT04120987Bucci Laser Vision Institute
已完成
4 期
Systane Clinical Experience StudyDry Eye SyndromeNCT00818909Alcon Research941
已完成
不适用
Ocular Effects of Scleral Lens Wear on Dry Eye PatientsDry EyeNCT05079321University of Waterloo30