Handling Comparison Between Two Contact Lens Types
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 16
- 主要终点
- Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
研究概览
简要总结
Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 between 40 and 70 years of age.
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
- •The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
- •The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
- •The subject best corrected visual acuity of 20/20 -3 or better in each eye.
- •Subject must own a wearable pair of spectacles.
- •The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
- •The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
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, which may interfere with contact lens wear.
- •Any ocular abnormality that may interfere with contact lens wear.
- •Use of any ocular medication, with the exception of rewetting drops.
- •Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- •Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- •Any ocular infection or inflammation.
- •History of herpetic keratitis.
- •Any corneal distortion or irregular cornea.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
- •Current history of diabetes.
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
研究组 & 干预措施
etafilcon A(sphere)/etafilcon A(multi-focal)
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.
干预措施: etafilcon A (multi-focal) (Device)
etafilcon A(sphere)/etafilcon A(multi-focal)
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.
干预措施: etafilcon A (sphere) (Device)
etafilcon A(multi-focal)/etafilcon A(sphere)
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.
干预措施: etafilcon A (multi-focal) (Device)
etafilcon A(multi-focal)/etafilcon A(sphere)
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.
干预措施: etafilcon A (sphere) (Device)
结局指标
主要结局
Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
时间窗: 15 minutes post Contact Lens Insertion
CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes 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 indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
次要结局
未报告次要终点