Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Subjective Rating of End of Day Dryness With Contact Lens Wear
研究概览
简要总结
The purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. Ocular signs and symptoms of dry eye will be assessed following the guidelines outlined by the Tear Film and Ocular Surface Society (TFOS) in the Dry Eye Workshop II (DEWS II). The performance of the habitual contact lenses and the study lenses will be determined using different optometric assessments. Study lenses will be worn for one month following a daily disposable wear schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants will be masked to the lens type (brand) they will be wearing during the study in order to reduce bias towards or against this product
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 17 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;
- •As per TFOS DEWS II, have dry eye symptoms (without CL wear) as determined by an OSDI score of ≥13 and at least one of the following:
- •Tear osmolarity ≥ 308mOsm/L or interocular difference >8 mOsm/L
- •Non-invasive tear breakup time of < 10 seconds in at least one eye
- •More than 5 spots of corneal staining OR > 9 conjunctival spots in at least one eye
- •Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203
- •Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D
- •Manifest spectacle cyl ≤1.00DC in either eye
- •BCVA ≤0.20 log MAR each eye with habitual & DT1
- •Acceptable fit with habitual & DT1
- •Willing to wear DT1 CLs at least 3 days per week and 6 hours per day throughout the study
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Has taken part in another clinical research study within the last 14 days;
- •Current habitual wearer of DT1
- •Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.
- •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.
结局指标
主要结局
Subjective Rating of End of Day Dryness With Contact Lens Wear
时间窗: 1-month follow up with delefilcon A
Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).
Subjective Comfort at End of Day With Contact Lens Wear
时间窗: 1-month follow up with delefilcon A
Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).
Comfortable Lens Wear Time
时间窗: 1-month follow up with delefilcon A
Comfortable lens wear time (Time of discomfort - Time of insertion)
Average Lens Wear Time
时间窗: 1-month follow up with delefilcon A
Average lens wear time is recorded
次要结局
未报告次要终点