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Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

Primary Purpose

Myopia, Refractive Error

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ReNu MultiPlus® MultiPurpose Solution
OPTI-FREE® RepleniSH®
Clear Care®
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myopia focused on measuring Contact lens, Lens care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Iowa
  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

OPTI-FREE® RepleniSH®

Clear Care®

ReNu MultiPlus® MultiPurpose Solution

Arm Description

33 participants will be assigned to use this lens care regimen during the six-week assessment period

33 participants will be assigned to use this lens care regimen during the six-week assessment period

33 participants will be assigned to use this lens care regimen during the six-week assessment period

Outcomes

Primary Outcome Measures

Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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.

Full Information

First Posted
November 29, 2010
Last Updated
November 11, 2016
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
University of Iowa, Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01250925
Brief Title
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
Official Title
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
University of Iowa, Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Refractive Error
Keywords
Contact lens, Lens care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPTI-FREE® RepleniSH®
Arm Type
Active Comparator
Arm Description
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Arm Title
Clear Care®
Arm Type
Active Comparator
Arm Description
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Arm Title
ReNu MultiPlus® MultiPurpose Solution
Arm Type
Active Comparator
Arm Description
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Intervention Type
Drug
Intervention Name(s)
ReNu MultiPlus® MultiPurpose Solution
Intervention Description
Contact lens care regimen
Intervention Type
Drug
Intervention Name(s)
OPTI-FREE® RepleniSH®
Intervention Description
Contact Lens care regimen
Intervention Type
Drug
Intervention Name(s)
Clear Care®
Intervention Description
Contact lens care regimen
Primary Outcome Measure Information:
Title
Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)
Description
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.
Time Frame
Six weeks
Title
Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)
Description
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.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events
Description
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.
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must be 18 years of age and may be of any race and either gender. Subjects must not have ever worn contact lenses. Subjects must have normal, healthy eyes. Exclusion Criteria: Subjects must not use additional lens cleaners. subjects must not have any ocular or systemic disease. Subjects must not have history of ocular surgery/trauma within the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedram Hamrah, MD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Sindt, OD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1091
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

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