Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
研究概览
简要总结
This study is a randomized, single-masked, crossover clinical trial. There are two study lenses. Each lens will be dispensed for 3 ± 1 days and then an optimization visit will occur. The final lens pair will be dispensed for 12 ± 2 days and the follow-up on the final lens pair will occur. The second study lenses will then be fit and the above sequence repeated.
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 at least 40 years of age and not greater than 70 years of age at the time of consent.
- •Subjects must own a wearable pair of 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 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 E).
- •The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 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:
- •Currently pregnant or lactating.
- •Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
- •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).
- •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.
- •Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines, oral/topical/inhaled anticholinergics, systemic/topical corticosteroids.
- •Use of any ocular medication, with the exception of rewetting drops.
- •History of herpetic keratitis.
- •History of irregular cornea.
- •History of pathological dry eye.
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution, sodium fluorescein or non-preserved rewetting drop solutions.
- •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.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
- •Any current ocular infection or inflammation.
- •Any current ocular abnormality that may interfere with contact lens wear.
结局指标
主要结局
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
时间窗: 2-Week Follow-up
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright
时间窗: 2-Week Follow-up
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles
时间窗: 2-Week Follow-up
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
次要结局
- Overall Vision Scores(2-Week Follow-up)
- Number of Grade 3 or Higher Slit Lamp Findings(2-Week Follow-up)
- Overall Comfort Scores(2-Week Follow-up)
- Proportion of Subjects That Reported Ocular Symptoms(2-Week Follow-up)