Evaluation of Two Marketed Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 10
- 主要终点
- Distance Binocular Visual Acuity
研究概览
简要总结
This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal 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
- 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
- •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.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be between at least 40 years of age and not greater than 70 years of age.
- •The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
- •The subject's refractive cylinder must be ≤ -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 must have best corrected visual acuity of 20/20-3 or better in each eye.
- •The subject must own a pair of wearable spectacles if required for their distance vision.
- •The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
- •The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
- •Pregnancy or lactation.
- •Currently diagnosed with diabetes.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
- •Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
- •Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
- •A history of amblyopia, strabismus or binocular vision abnormality.
- •Any ocular infection or inflammation.
- •Any ocular abnormality that may interfere with contact lens wear.
- •Use of any ocular medication, with the exception of rewetting drops.
- •History of herpetic keratitis.
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- •Employee of clinical site (e.g., Investigator, Coordinator, Technician)
研究组 & 干预措施
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.
干预措施: Multifocal Contact Lens 1 (Device)
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.
干预措施: Multifocal Contact Lens 1 (Device)
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.
干预措施: Multifocal Contact Lens 2 (Device)
Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.
干预措施: Spherical Contact Lens 2 (Device)
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.
干预措施: Multifocal Contact Lens 2 (Device)
Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.
干预措施: Spherical Contact Lens 2 (Device)
结局指标
主要结局
Distance Binocular Visual Acuity
时间窗: 1-Week Follow-up
Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Near Binocular Visual Acuity
时间窗: 1-Week Follow-up
Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.
次要结局
- Overall Quality of Vision(1-Week Follow-up)