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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts Eye and Ear Infirmary.
Recruitment status was  Active, not recruiting
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: April 10, 2012
Last verified: April 2012

November 29, 2010
April 10, 2012
August 2010
September 2012   (final data collection date for primary outcome measure)
Corneal Epithelial Immune Status [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01250925 on ClinicalTrials.gov Archive Site
Safety Analysis [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
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.
Same as current
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
Endpoint Classification: Efficacy Study
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.
 
Active, not recruiting
100
September 2012
September 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250925
10-04-029
No
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 2012

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