Overview

This trial is active, not recruiting.

Conditions myopia, refractive error
Treatments renu multiplus® multipurpose solution, opti-free® replenish®, clear care®
Phase phase 4
Sponsor Massachusetts Eye and Ear Infirmary
Collaborator University of Iowa
Start date August 2010
End date September 2012
Trial size 100 participants
Trial identifier NCT01250925, 10-04-029

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(Active Comparator)
33 participants will be assigned to use this lens care regimen during the six-week assessment period
opti-free® replenish®
Contact Lens care regimen
(Active Comparator)
33 participants will be assigned to use this lens care regimen during the six-week assessment period
clear care®
Contact lens care regimen
(Active Comparator)
33 participants will be assigned to use this lens care regimen during the six-week assessment period
renu multiplus® multipurpose solution
Contact lens care regimen

Primary Outcomes

Measure
Corneal Epithelial Immune Status
time frame: Six weeks

Secondary Outcomes

Measure
Safety Analysis
time frame: Six weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
Principal investigator Pedram Hamrah, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary.