Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 7
- 主要终点
- High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at distance (4 meters)
研究概览
简要总结
This is a 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial 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
- 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:
- •Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Be at least 40 years of age and not greater than 70 years of age at the time of consent.
- •Own a wearable pair of spectacles if required for their distance vision.
- •Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 30 days or more duration).
- •Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, monovision or multifocal contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
- •The subject's distance spherical equivalent refraction must be in the range of +1.00 to +4.00 or -1.00 D to -4.00 D in each eye.
- •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.
- •The subject must have distance best corrected visual acuity of 20/20-3 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.
- •Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
- •Have been diagnosed with diabetes.
- •Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This includes, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- •Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
- •Have a history of amblyopia, strabismus or binocular vision abnormality.
- •Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.
- •Be currently using any ocular medications with the exception of rewetting drops.
- •Have a history of herpetic keratitis.
- •Have a history of irregular cornea.
- •Have a history of pathological dry eye.
- •Have participated in any contact lens or lens care product clinical trial within 7 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, sibling of the employee or their spouse) of the clinical site.
- •Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
- •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 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 any current ocular infection or inflammation.
排除标准
- 未提供
研究组 & 干预措施
Test/Control/Control
Eligible subjects will be randomized into the Test/Control/Control sequence.
干预措施: INFUSE® One Day Multifocal (Device)
Test/Control/Control
Eligible subjects will be randomized into the Test/Control/Control sequence.
干预措施: ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens (Device)
Control/Test/Test
Eligible subjects will be randomized into the Control/Test/Test sequence.
干预措施: INFUSE® One Day Multifocal (Device)
Control/Test/Test
Eligible subjects will be randomized into the Control/Test/Test sequence.
干预措施: ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens (Device)
结局指标
主要结局
High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at distance (4 meters)
时间窗: 1-week follow-up
Visual acuity after approximately 1-week in the optimized lens pair under HLHC illuminance conditions will be evaluated at distance (4 meters) using ETDRS Charts.
High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at intermediate (64 cm)
时间窗: 1-week follow-up
Visual acuity after approximately 1-week in the optimized lens pair under HLHC illuminance conditions will be evaluated at intermediate (64 cm) using reduced Guillon-Poling charts.
High Luminance, High Contrast (HLHC) Binocular logMAR Visual Acuity at near (40 cm)
时间窗: 1-week follow-up
Visual acuity after approximately 1-week in the optimized lens pair under HLHC illuminance conditions will be evaluated at near (40 cm) using reduced Guillon-Poling charts.
次要结局
未报告次要终点