Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Proportion of Eyes With Acceptable Lens Fitting
研究概览
简要总结
This is a subject-masked, randomized, bilateral, 2x2 crossover clinical investigation that will assess lens fit acceptance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Between 18 and 40 (inclusive) years of age at the time of screening.
- •They agree not to participate in other clinical research while enrolled on this study.
- •They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks.
- •They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
- •They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
- •They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).
- •They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating.
- •Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.
- •They have an ocular disorder which would normally contraindicate contact lens wear.
- •They have had cataract surgery.
- •They have had corneal refractive surgery.
- •They are using any topical medications such as eye drops or ointments.
- •Any known hypersensitivity or allergic reaction to sodium fluorescein.
- •Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
- •Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection),
- •They have a pre-corneal tear film break-up time less than five seconds when evaluated on the DESMD tear film imaging system.
研究组 & 干预措施
Test/Control
Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.
干预措施: Acuvue® Oasys MAX 1-Day (Device)
Test/Control
Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.
干预措施: Dailies Total 1 (Device)
Control/Test
Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.
干预措施: Acuvue® Oasys MAX 1-Day (Device)
Control/Test
Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.
干预措施: Dailies Total 1 (Device)
结局指标
主要结局
Proportion of Eyes With Acceptable Lens Fitting
时间窗: Up to 2-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1- and 2-week follow-up evaluations and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported.
次要结局
未报告次要终点