Evaluation of Approved Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visit
研究概览
简要总结
This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity.
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 39 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:
- •Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •3. Be between 18 and 39 (inclusive) years of age at the time of screening.
- •By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
- •5. Have a habitual contact lens prescription that is current (no power change needed) within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
- •6. Possess a wearable pair of spectacles that provide correction for distance vision.
- •7. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye.
- •8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Be currently pregnant or lactating.
- •Be currently using any ocular medications or have any ocular infection of any type.
- •By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
- •Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- •Be currently wearing monovision or multifocal contact lenses.
- •Be currently wearing lenses in an extended wear modality.
- •Have a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses.
- •Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- •Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- •Have a history of strabismus or amblyopia.
- •Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- •Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
排除标准
- 未提供
研究组 & 干预措施
Test/Control/Control
Eligible subjects will be randomized to the test/control/control sequence, to wear the test lens, the control lens, and the control lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.
干预措施: B+L Infuse spherical soft contact lenses (Device)
Test/Control/Control
Eligible subjects will be randomized to the test/control/control sequence, to wear the test lens, the control lens, and the control lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.
干预措施: J&J ACUVUE OASYS 1-Day spherical soft contact lenses (Device)
Control/Test/Test
Eligible subjects will be randomized to the control/test/test sequence, to wear the control lens, the test lens, and the test lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.
干预措施: B+L Infuse spherical soft contact lenses (Device)
Control/Test/Test
Eligible subjects will be randomized to the control/test/test sequence, to wear the control lens, the test lens, and the test lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.
干预措施: J&J ACUVUE OASYS 1-Day spherical soft contact lenses (Device)
结局指标
主要结局
Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visit
时间窗: At 1-week follow-up per wear period
Visual acuity (VA) will be collected for each eye at distance using Snellen charts at the fitting evaluation and after approximately 1-week of lens wear.
Proportion of Eyes with acceptable lens fit
时间窗: Up to 3-week follow-up
Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each eye.
次要结局
未报告次要终点