A Comparison of the Effects of Alcon DAILIES TOTAL1 and a Control High Oxygen Permeable Silicone Hydrogel Daily Disposable Contact Lens, the ACUVUE TruEye, on the Biology of the Ocular Surface and Lid Margin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Desquamation Rate of Wearing Acuvue TruEye, Then Alcon DAILIES Contact Lenses
研究概览
简要总结
This is a prospective, single center, randomized, bilateral crossover, dispensing clinical trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of corneal epithelium over two months of daily wear compared to wear of a control high oxygen permeable silicone hydrogel daily disposable contact lens, the ACUVUE TruEye; and to correlate these changes with alterations in the lid wiper, tear film and cellular changes at the limbus. The total proposed duration of this study is 12 months to ensure enrollment of up to 94 established contact lens wearers, with anticipated completion of 84. Data will be collected at baseline and following 2 months of daily wear for each lens type. Based upon data from the investigators previous contact lens clinical trials, a 1 month washout period is required prior to initiating lens wear and also between lens wear periods for the two types of lenses in order to eliminate any potential residual solution or lens effects on the corneal epithelium and restore homeostasis. The study is scheduled to commence upon Institutional Review Board approval.
详细描述
The following Standard of Care procedures will be performed during this study:
I.Medical history and Concomitant Medication Recorded - Subjects will be interviewed about their demographics, medical and ocular History, and their allergies and medications. The study doctor or the study personnel will use paper source documents (Case Report Form) to collect and record the following data: current prescription of both contact lenses and glasses, refraction, and keratometry.
II.Comprehensive Exam
A. Snellen visual acuity testing (both eyes) This will be performed using a standard projector chart at twenty feet. All patients will be refracted to ensure that visual acuity and prescription are within the inclusion criteria.
B. Anterior ocular segment inspection by slit lamp examination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21-38 years
- •Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged
- •Sign written informed consent
- •A habitual contact lens wearer and only wear lenses for daily wear use (no overnight wear)
- •Myopia range: -1.00 to -6.00 with regular astigmatism (≤1 Diopter, both eyes)
- •Be willing to wear spectacles for two 1-month washout periods
- •Have acceptable fit with test lenses and be willing to wear lenses for the duration of the study.
- •Need correction in both eyes and be correctable to within 3 letters (high contrast Snellen VA) of their current contact lens prescription at baseline in each eye with the test lenses.
- •No history of allergic eye disease either seasonal or associated with previous contact lens wear.
- •A routine screening complete ocular examination (COE) with ocular findings considered to be within normal limits.
- •Be willing and able to follow instructions regarding the wear of the daily disposable lenses and attend the scheduled follow-up visits.
- •Must be able to arrange weekday appointments between 8:00 (morning) and 12:00 (noon).
排除标准
- •Habitual lens wearers unable to wear lenses for a minimum of 8 hours per day.
- •Use of concurrent ocular medication
- •Habitual toric or bifocal contact lens wearers
- •Any previous history of keratorefractive surgery or recent ocular injuries or ocular surgery within the prior 3 months
- •Any preexisting ocular disease
- •Monocular contact lens wear
- •Any systemic disease or ocular abnormality that may impact optimal contact lens wear
- •Use of systemic medications including but not limited to antihistamines, corticosteroids, anticholinergics or immunomodulatory agents
- •Pregnancy or lactation
- •Concurrent enrollment in another clinical trial
结局指标
主要结局
Desquamation Rate of Wearing Acuvue TruEye, Then Alcon DAILIES Contact Lenses
时间窗: Baseline + 3 months
Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Acuvue TRUEYE contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 2.
Desquamation Rate of Wearing Alcon DAILIES, Then AcuVue TruEye Contact Lenses
时间窗: Baseline + 3 months
Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing AcuVue TRUEYE contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 2.
次要结局
未报告次要终点
研究者
Danielle Robertson
O.D., Ph.D - Clinician Scientist
University of Texas Southwestern Medical Center