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Evaluation of an Investigational Multifocal Lens

2018年6月18日 更新者：Johnson & Johnson Vision Care, Inc.
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

371

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

  • 美国
    • Alabama
      • Montgomery、Alabama、美国、36109
    • California
      • Mission Viejo、California、美国、92691
    • Florida
      • Jacksonville、Florida、美国、32205
      • Jacksonville、Florida、美国、32250
      • Orange Park、Florida、美国、32065
      • Saint Augustine、Florida、美国、32092
      • Tallahassee、Florida、美国、32308
      • Tampa、Florida、美国、33625
      • Winter Park、Florida、美国、32792
    • Georgia
      • Roswell、Georgia、美国、30076
    • Kansas
      • Pittsburg、Kansas、美国、66762
    • Michigan
      • East Lansing、Michigan、美国、48823
    • New York
      • Vestal、New York、美国、13850
    • North Carolina
      • Denver、North Carolina、美国、28037
    • Ohio
      • Powell、Ohio、美国、43065
      • Springfield、Ohio、美国、45503
    • Rhode Island
      • Warwick、Rhode Island、美国、02888
    • Tennessee
      • Memphis、Tennessee、美国、38119
    • Texas
      • Tyler、Texas、美国、75701
    • Virginia
      • Salem、Virginia、美国、24153

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:

  1. The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Between 40 and 70 years of age.
  4. Subjects must own a wearable pair of spectacles, if required for their distance vision.
  5. 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)
  6. 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"*
  7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
  8. Refractive cylinder ≤ -0.75 D in each eye.
  9. ADD power in the range +0.75 D to +2.50 D in each eye.
  10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
  2. Any ocular or systemic allergies that may have contraindicated contact lens wear.
  3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
  4. Any ocular abnormality that may have interfered with contact lens wear.
  5. Use of any ocular medication, with the exception of rewetting drops.
  6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  7. History of herpetic keratitis.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
  10. History of diabetes.
  11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
  13. Any ocular infection or inflammation.
  14. Any corneal distortion or irregular cornea.

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：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：lotrafilcon B / etafilcon A
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
设备：lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
其他名称：
  • AirOptix Aqua 多焦点
设备：etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.
实验性的：etafilcon A / lotrafilcon B
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
设备：lotrafilcon B
Soft contact lens to be worn as daily wear, monthly replacement modality.
其他名称：
  • AirOptix Aqua 多焦点
设备：etafilcon A
Soft contact lens to be worn as daily wear, daily disposable modality.

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
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
大体时间：8 -12 days post wear
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
8 -12 days post wear
Distance Binocular Visual Acuity (LogMAR)
大体时间：8- 12 Days post wear
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
8- 12 Days post wear
Intermediate Binocular Visual Acuity (LogMAR)
大体时间：8-12 days post wear
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
8-12 days post wear
Near Binocular Visual Acuity (LogMAR)
大体时间：8-12 days post wear
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
8-12 days post wear
Corneal Staining
大体时间：8 - 12 Days post wear
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
8 - 12 Days post wear
Bulbar Conjunctival Injection
大体时间：8- 12 Days post wear
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
8- 12 Days post wear
Limbal Conjunctival Injection
大体时间：8- 12 Days post wear
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
8- 12 Days post wear
Contact Lens Fitting
大体时间：8- 12 Days post wear
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
8- 12 Days post wear

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。

赞助

Johnson & Johnson Vision Care, Inc.

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

2014年8月1日

初级完成 (实际的)

2014年11月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2014年8月20日

首先提交符合 QC 标准的

2014年8月20日

首次发布 (估计)

2014年8月22日

研究记录更新

最后更新发布 (实际的)

2018年6月19日

上次提交的符合 QC 标准的更新

2018年6月18日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CR-5593

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.

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