NCT07788521尚未招募不适用
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.
研究概览
简要总结
This study is a 4-visit, multi-site, prospective, controlled, randomized, single-masked (subjects), two-arm parallel group, bilateral, dispensing clinical trial to compare the performance of the Test lens to the Control lens in terms of safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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, multifocal or monovision 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 (vertex corrected if ≥-4.25 D) must be in the range of -1.50 D to -5.50 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 0.0 logMAR (20/20 Snellen, 5.0 on the China standard 5-point logMAR visual acuity scale) 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 may include, 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.
- •Use of any ocular medication.
- •Have a history of herpetic keratitis.
- •Have a history of irregular cornea.
- •Have a history of pathological dry eye.
- •Have a history of glaucoma or glaucoma suspect.
- •Have a history of any retinal disease/condition that may interfere with any of the study assessments or are not stable and have potential to progress during the study.
- •Have participated in any contact lens or lens care product clinical trial within 15 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 sodium fluorescein.
- •Have Grade 3 or greater palpebral conjunctival observations or Grade 2 or greater slit lamp findings (e.g. corneal edema, corneal vascularization, corneal staining, bulbar injection, etc.) on the ISO 11980 classification scale, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- •Have any current ocular infection or inflammation.
- •Have intraocular pressure in one or both eyes >21mmHg
- •Have signs of any retinal disease/conditions that may interfere with any of the study assessments or are not stable and have potential to progress during the study.
排除标准
- 未提供
研究组 & 干预措施
Senofilcon A
Experimental
Eligible subjects will be randomized to the Senofilcon A Lens for the duration of the study.
干预措施: Senofilcon A (Device)
Nelfilcon A
Active Comparator
Eligible subjects will be randomized to the Nelfilcon A Lens for the duration of the study.
干预措施: Nelfilcon A (Device)
结局指标
主要结局
Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.
时间窗: Up to 1-month follow-up
Mean binocular HLHC distance Visual Acuity
时间窗: At 1-week follow-up
Mean binocular HLHC VA at distance (4m)
Mean binocular HLHC Intermediate Visual Acuity
时间窗: At 1-week follow-up
Mean binocular HLHC VA at Intermediate (64cm)
Mean binocular HLHC Near Visual Acuity
时间窗: At 1-week follow-up
Mean binocular HLHC VA at Near (40cm)
次要结局
- Mean binocular HLHC distance Visual Acuity(At 1-month follow-up)
- Mean binocular HLHC Intermediate Visual Acuity(At 1-month follow-up)
- Mean binocular HLHC Near Visual Acuity(At 1-month follow-up)
- Incidence rate of Slit Lamp Findings (SLF)(Up to 1-month follow-up)
研究者
研究点 (10)
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