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.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia
• Intervention / Treatment: Drug: OPTI-FREE® RepleniSH®; Drug: Clear Care®; Drug: ReNu MultiPlus® MultiPurpose Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242-1091
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six weeks
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.	Six weeks
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.	Six weeks
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.	Six weeks
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.	Six weeks
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.	Six weeks
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.	Six weeks
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.	Six weeks
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.	Six weeks
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.	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six weeks

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborators: University of Iowa; Alcon Research
• Investigators: Principal Investigator: Christine Sindt, OD, University of Iowa

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (ESTIMATE): December 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2017
• Last Update Submitted That Met QC Criteria: November 11, 2016
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Contact lens; Lens care
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 10-04-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO