Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 7
- 主要终点
- Overall Comfort
研究概览
简要总结
To evaluate the clinical performance of daily disposable etafilcon A lenses.
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
- 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 < 1.00 Diopters (D) in each eye.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
- •The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.
- •The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
- •The subject must self-report their race as Asian
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- •The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.
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.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (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 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
Etafilcon A Test Lens
etafilcon A
干预措施: etafilcon A (Device)
Etafilcon A Control Lens
etafilcon A
干预措施: etafilcon A (Device)
结局指标
主要结局
Overall Comfort
时间窗: 1-week follow-up
Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Overall Vision
时间窗: 1- week Follow-up
Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim
时间窗: 1-week follow-up
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Monocular logMar Visual Acuity - Standard Low Contrast Bright
时间窗: 1- week Follow-up
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
次要结局
未报告次要终点