Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8
研究概览
简要总结
This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must read, understand and sign the Statement of Informed Consent
- •Subjects must be at least 18 years of age
- •Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule
- •Habitual contact lenses must have a suitable fit as determined by the investigator
- •Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days
- •Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study
- •Subjects must have a score of 12 or higher on the CLDEQ (Contact Lens Dry Eye Questionnaire-8) at baseline
- •Subjects must have at least 2 of the following signs of dry eye disease:
- •High tear osmolarity > 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes
- •Any corneal staining
- •Any bulbar conjunctival staining
- •Low TBUT (tear break up time) (<10s)
- •Schirmer <10mm in either eye
- •Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription.
- •Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.
排除标准
- •Currently pregnant or breastfeeding by self-report
- •Allergy to lifitegrast ophthalmic solution 5% (Xiidra)
- •Habitual extended wear contact lens schedule
- •Any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.)
- •Any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the Efron Grading Scale.
- •Excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use.
- •History of ocular surgery
- •Any active ocular infection
- •Use of any topical ophthalmic medications other than artificial tears or rewetting drops
- •Inability to perform necessary visual function assessments
- •Punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.
研究组 & 干预措施
Lifitegrast Ophthalmic Solution 5%
干预措施: Lifitegrast 5% Ophthalmic Solution (Drug)
Lifitegrast Ophthalmic Solution Vehicle
干预措施: Lifitegrast Ophthalmic Solution Vehicle (Other)
结局指标
主要结局
Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8
时间窗: 8 weeks
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 8. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 8 than baseline).
次要结局
- Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks(2 weeks)
- Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks(4 weeks)
- Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8(8 weeks)
- Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8(8 weeks)
- Forced Choice Questionnaire(8 weeks)
- Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8(8 weeks)
研究者
Danielle Iacono
Associate Clinical Professor
State University of New York College of Optometry