Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population
Clinical Evaluation of Manufacturing Curing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Florida
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Maitland、Florida、美国、32751
- Maitland Vision Center
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Missouri
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Raytown、Missouri、美国、64133
- Advanced Eyecare
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New York
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Jamestown、New York、美国、14701
- Spectrum Eyecare
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Ohio
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Beachwood、Ohio、美国、44122
- Western Reserve Vision Care, Inc
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Granville、Ohio、美国、43023
- Procare Vision Centers
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Potential subjects must satisfy all 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.
- 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.
- 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 of 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".
Exclusion Criteria:
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).
- Clinically significant (Grade 3 or 4) 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, dry eye, glaucoma, history of recurrent corneal erosions.
- Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy cataract surgery, retinal surgery, etc.).
- A history of amblyopia, strabismus or binocular vision abnormality.
- Any current ocular infection or inflammation.
- Any current ocular abnormality that may interfere with contact lens wear.
- Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, systemic steroids.
- Use of any ocular medication, with the exception of rewetting drops.
- History of herpetic keratitis.
- 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 Eye-Cept® rewetting drop solution.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Test/Control
Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into one the sequence (Test/Control).
|
CONTROL
TEST
|
实验性的:Control/Test
Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into the sequence (Control/Test).
|
CONTROL
TEST
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
线索愿景
大体时间:2周随访
|
使用 Contact Lens User Experience™ (CLUE) 问卷评估总体视力。
CLUE 是经过验证的患者报告结果 (PRO) 问卷,用于评估美国 18-65 岁隐形眼镜佩戴人群中软性隐形眼镜的患者体验属性(舒适度、视力、操作和包装)。
使用项目反应理论 (IRT) 得出的 CLUE 分数遵循正态分布,人口平均分数为 60 (SD 20),其中较高的分数表示更有利/积极的反应,范围为 0-120。
|
2周随访
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
logMAR Visual Acuity
大体时间:2-Week Follow-up
|
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances: Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured 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. |
2-Week Follow-up
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CR-6317
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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