Comparison of Three Soft Bifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
研究概览
简要总结
The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the 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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must between 35 and 70 years of age.
- •The subject must respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).
- •The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
- •Refractive cylinder must be less than or equal to -0.75 D in each eye.
- •The subject must have an add power of +0.75D to +2.50D in each eye.
- •The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- •The subject's must have at least 20/30-distance vision with the study contact lenses.
- •The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses.
- •The subject must be an adapted soft contact lens wearer in both eyes.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
排除标准
- •Ocular or systemic allergies or disease that may interfere with contact lens wear.
- •Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Pregnancy or lactation
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
- •History of diabetes. History of binocular vision abnormality or strabismus.
结局指标
主要结局
Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity
时间窗: 5 minutes after insertion
Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity
时间窗: 5 minutes after insertion
Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Type of Corneal Staining
时间窗: after 1 week of lens wear, for each lens type
Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(\> or = to mm).
Overall Subjective Vision
时间窗: after 1 week of lens wear, for each lens type
Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
次要结局
未报告次要终点