Clinical Evaluation of Fitting Investigational Contact Lenses
2018年5月24日 更新者:Johnson & Johnson Vision Care, Inc.
This study is a non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit.
The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection.
Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes.
This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.
研究概览
研究类型
介入性
注册 (实际的)
23
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
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Jacksonville、Florida、美国、32256
- Vistakon Research Clinic
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
- Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
- The subject must either 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 is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
- The subject's distance spherical equivalent or spherical component (if fit with a toric lens) of their refraction must be in the range -1.25 D to -3.75 D in each eye.
- The subject's refractive cylinder must be 0.00 D to -1.50 D in at least one eye and no greater than -1.50 D in either eye.
- The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
- 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 visual acuity of 20/20-3 or better in each eye.
- The subject must have a wearable pair of spectacles if required for their distance vision.
Exclusion Criteria:
- Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
- Pregnancy or lactation.
- Currently diagnosed with diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
- 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, cataract surgery, retinal surgery, etc.).
- A history of amblyopia, strabismus or binocular vision abnormality.
- Any ocular infection or inflammation.
- Any ocular abnormality that may interfere with contact lens wear.
- 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 of clinical site (e.g., Investigator, Coordinator, Technician)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:etafilcon A Toric Multifocal
|
Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50.
The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.
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有源比较器:etafilcon A Multifocal
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Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50.
The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.
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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 |
|---|---|---|
|
The Average Number of Fitting Modifications to Optimize Vision
大体时间:15 minutes post lens insertion
|
The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed.
The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide.
Up to two modifications per subject was allowed.
The number of modifications required by the ECP to optimize vision was reported.
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15 minutes post lens insertion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subject's Responses to Individual Item 1
大体时间:15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?".
This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
|
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Subject's Responses to Individual Item 2
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?".
This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
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Subject's Responses to Individual Item 3
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses.
Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?".
This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
|
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Subject's Responses to Individual Item 4
大体时间:15 Minuted Post Lens Insertion
|
Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens?
Please Select All That Apply.".
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
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Subject's Responses to Individual Item 5
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?".
This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
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Subject's Responses to Individual Item 6
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "What Are Your Current Vision Correction Solutions?".
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
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Subject's Responses to Individual Item 7
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "Study Compare To Your Current Vision Correction Solutions?".
This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
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Subject's Responses to Individual Item 8
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?".
This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
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Subject's Responses to Individual Item 9
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?".
This item had a response set of Excellent, Very Good, Good, Fair and Poor.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
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Subject's Responses to Individual Item 10
大体时间:15 Minuted Post Lens Insertion
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Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?".
This item had a response set of Excellent, Very Good, Good, Fair and Poor.
The percentage of subject's in each response category was reported.
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15 Minuted Post Lens Insertion
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月27日
初级完成 (实际的)
2017年3月31日
研究完成 (实际的)
2017年3月31日
研究注册日期
首次提交
2017年4月17日
首先提交符合 QC 标准的
2017年5月9日
首次发布 (实际的)
2017年5月12日
研究记录更新
最后更新发布 (实际的)
2018年6月29日
上次提交的符合 QC 标准的更新
2018年5月24日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.