Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 12
- 主要终点
- Clarity of Vision in Dim or Low Lighting
研究概览
简要总结
This is a single-masked, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate overall quality of vision.
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 1 month or more duration).
- •Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (Appendix D).
- •The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 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.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •The subject must not:
- •Be currently pregnant or lactating.
- •Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
- •Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, 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.
- •Use of any ocular medication, 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 30 days prior to study enrollment.
- •Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
- •Have clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- •Have any current ocular infection or inflammation.
- •Have any current ocular abnormality that may interfere with contact lens wear.
研究组 & 干预措施
TEST/CONTROL/CONTROL
Eligible subjects will be randomized into the sequence TEST/CONTROL/CONTROL.
干预措施: JJVC Investigational Multifocal Contact Lenses (Device)
TEST/CONTROL/CONTROL
Eligible subjects will be randomized into the sequence TEST/CONTROL/CONTROL.
干预措施: Dailies Total 1® Multifocal Contact Lenses (Device)
CONTROL/TEST/TEST
Eligible subjects will be randomized into the sequence CONTROL/TEST/TEST
干预措施: JJVC Investigational Multifocal Contact Lenses (Device)
CONTROL/TEST/TEST
Eligible subjects will be randomized into the sequence CONTROL/TEST/TEST
干预措施: Dailies Total 1® Multifocal Contact Lenses (Device)
结局指标
主要结局
Clarity of Vision in Dim or Low Lighting
时间窗: 1-Week Follow-up
Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
Clarity of Vision When Reading in Dim Light
时间窗: 1-Week Follow-up
Clarity of vision when reading in dim light was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision when reading in dim light(e.g., menu or bill in a restaurant). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
次要结局
- Clarity of Distance Vision(1-Week Follow-up)
- Clarity of Intermediate Vision(1-Week Follow-up)
- Clarity of Near Vision(1-Week Follow-up)