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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
  Purpose
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.

Condition Intervention Phase
Myopia
Refractive Error
Drug: ReNu MultiPlus® MultiPurpose Solution
Drug: OPTI-FREE® RepleniSH®
Drug: Clear Care®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 94
Study Start Date: August 2010
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OPTI-FREE® RepleniSH®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Drug: OPTI-FREE® RepleniSH®
Contact Lens care regimen
Active Comparator: Clear Care®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Drug: Clear Care®
Contact lens care regimen
Active Comparator: ReNu MultiPlus® MultiPurpose Solution
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Drug: ReNu MultiPlus® MultiPurpose Solution
Contact lens care regimen

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250925

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242-1091
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
University of Iowa
Alcon Research
Investigators
Principal Investigator: Pedram Hamrah, MD Massachusetts Eye and Ear Infirmary
Principal Investigator: Christine Sindt, OD University of Iowa
  More Information

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01250925     History of Changes
Other Study ID Numbers: 10-04-029
Study First Received: November 29, 2010
Results First Received: April 24, 2013
Last Updated: November 11, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massachusetts Eye and Ear Infirmary:
Contact lens
Lens care

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 25, 2017