Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 4
- 主要终点
- Subjective Overall Comfort (Using CLUE )
研究概览
简要总结
To evaluate the impact of a new contact lens hydration process
详细描述
To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be at least 18 and not more than 70 years of age.
- •The subject's refractive cylinder must be < 0.75D in each eye.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
- •The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses.
- •The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.
- •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 -0.50 to -9.00D in each eye.
排除标准
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •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.
- •Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.
- •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 of investigational clinic (e.g., Investigator, Coordinator, Technician)
研究组 & 干预措施
Control, senofilcon A
Subjects received Control lens, senofilcon A during the first two weeks of the study then Test lens, senofilcon A in the last two weeks of the study.
干预措施: senofilcon A (Device)
Test, senofilcon A
Subjects received Test lens, senofilcon A during the first two weeks of the study then Control lens, senofilcon A in the last two weeks of the study.
干预措施: senofilcon A (Device)
结局指标
主要结局
Subjective Overall Comfort (Using CLUE )
时间窗: 2 weeks
Contact Lens User Experience Comfort scores (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.
Subjective Overall Vision (Using CLUE )
时间窗: 2 weeks
Contact Lens User Experience Vision scores (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.
次要结局
未报告次要终点