Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 12
- 主要终点
- Overall Vision Scores
研究概览
简要总结
This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older 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.
- •Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
- •The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- •The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
- •The subject's refractive cylinder must be < 0.75 D in each eye.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
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 (subjects who become pregnant during the study will be discontinued).
- •Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Monovision or multi-focal contact lens correction.
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
- •Suspicion of or recent history of alcohol or substance abuse.
- •History of serious mental illness.
- •History of seizures.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale.
- •Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
研究组 & 干预措施
TEST/CONTROL
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence.
干预措施: etafilcon A with novel molding process (Device)
TEST/CONTROL
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence.
干预措施: etafilcon A with current molding process (Device)
CONTROL/TEST
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence.
干预措施: etafilcon A with novel molding process (Device)
CONTROL/TEST
Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence.
干预措施: etafilcon A with current molding process (Device)
结局指标
主要结局
Overall Vision Scores
时间窗: 1-week Follow-up
Overall vision was assessed using the CLUE questionnaire. CLUE is a validated PRO questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using IRT follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Overall Comfort Scores
时间窗: 1-week Follow-up
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
次要结局
- LLHC LogMAR Visual Performance(1-week Follow-up)
- Average Daily Wear Time(1-week Follow-up)
- HLLC LogMAR Visual Performance(1-week Follow-up)