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

Myopia Clinical Trial

Official title:

Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01250925
• Other study ID #: 10-04-029
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: April 10, 2012
• Start date: August 2010
• Est. completion date: September 2012

Study information

• Verified date: April 2012
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Drug:
• ReNu MultiPlus® MultiPurpose Solution
Contact lens care regimen
• OPTI-FREE® RepleniSH®
Contact Lens care regimen
• Clear Care®
Contact lens care regimen

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	University of Iowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	Alcon Research, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Epithelial Immune Status	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.	Six weeks	No
Secondary	Safety Analysis	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	Yes