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Trial record 1 of 1 for:    NCT01250925
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Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

This study has been completed.
Sponsor:
Collaborators:
University of Iowa
Alcon Research
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01250925
First received: November 29, 2010
Last updated: November 11, 2016
Last verified: April 2013

November 29, 2010
November 11, 2016
August 2010
February 2012   (Final data collection date for primary outcome measure)
  • Corneal Epithelial Immune Dendritic Cell Density (Central Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
  • Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea) [ Time Frame: Six weeks ]
    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Status [ Time Frame: Six weeks ]
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells and immune cell morphology.
Complete list of historical versions of study NCT01250925 on ClinicalTrials.gov Archive Site
Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events [ Time Frame: Six weeks ]
The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.
Safety Analysis [ Time Frame: Six weeks ]
The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.
Not Provided
Not Provided
 
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.
An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
  • Myopia
  • Refractive Error
  • Drug: ReNu MultiPlus® MultiPurpose Solution
    Contact lens care regimen
  • Drug: OPTI-FREE® RepleniSH®
    Contact Lens care regimen
  • Drug: Clear Care®
    Contact lens care regimen
  • Active Comparator: OPTI-FREE® RepleniSH®
    33 participants will be assigned to use this lens care regimen during the six-week assessment period
    Intervention: Drug: OPTI-FREE® RepleniSH®
  • Active Comparator: Clear Care®
    33 participants will be assigned to use this lens care regimen during the six-week assessment period
    Intervention: Drug: Clear Care®
  • Active Comparator: ReNu MultiPlus® MultiPurpose Solution
    33 participants will be assigned to use this lens care regimen during the six-week assessment period
    Intervention: Drug: ReNu MultiPlus® MultiPurpose Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
July 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects must be 18 years of age and may be of any race and either gender.
  2. Subjects must not have ever worn contact lenses.
  3. Subjects must have normal, healthy eyes.

Exclusion Criteria:

  1. Subjects must not use additional lens cleaners.
  2. subjects must not have any ocular or systemic disease.
  3. Subjects must not have history of ocular surgery/trauma within the last 6 months.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01250925
10-04-029
No
Not Provided
No
Not Provided
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
  • University of Iowa
  • Alcon Research
Principal Investigator: Pedram Hamrah, MD Massachusetts Eye and Ear Infirmary
Principal Investigator: Christine Sindt, OD University of Iowa
Massachusetts Eye and Ear Infirmary
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP