Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 30
- 主要终点
- HLHC Binocular logMAR Visual Acuities
研究概览
简要总结
This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 and not more than 70 years of age at the time of screening.
- •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 for at least 8 hours per day at least two days per week for the past 4 weeks).
- •Be already 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 component of their refraction must be in the range of either -1.25 D to -3.75 D, or +1.25 D to +4.25 D.
- •The subject's refractive cylinder must be in the range of -1.00 D to -1.75 D in each eye, with the cylinder axes in the range of either 90°±15° or 180°±15°.
- •The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
- •The subject must have best corrected distance 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.
- •By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, which are known to interfere with contact lens wear and/or participation in the study.
- •Use systemic medications that may interfere with contact lens wear or cause blurred vision. See Section 9.1 for additional details regarding excluded systemic medications.
- •Currently use ocular medication (with the exception of rewetting drops).
- •Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
- •Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.).
- •Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report.
- •Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Have a history of amblyopia or strabismus, by self-report.
- •Have a history of herpetic keratitis, by self-report.
- •Have ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.
结局指标
主要结局
HLHC Binocular logMAR Visual Acuities
时间窗: 2-Week Follow-up
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.
CLUE Vision Scores
时间窗: 2-Week Follow-up
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
时间窗: 15-minutes after lens insertion
Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
时间窗: 15-minutes after lens insertion
Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
时间窗: Up to 2-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. Data from the hyperope and myopes group were combined for this outcome since the rate of SFLs grade 3+ is similar for these two populations.
Proportion of Eyes With Unacceptable Lens Fitting
时间窗: Up to 2-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where unacceptable lens fit=1 and acceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristics are similar for these two populations.
次要结局
- CLUE Vision Scores(2-Week Follow-up)
- CLUE Comfort Scores(2-Week Follow-up)
- CLUE Handling Scores(2-Week Follow-up)
- Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less.(Up to 1-Week Follow-up)