NCT01379768

Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear

Polymorphonuclear Leukocyte Response During Overnight Lens Wear

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: CIBA VISION · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep. The results from contact lens wearers were compared with the results from non-contact lens wearers.

Detailed description

The objective of the study was to determine and compare the relative oxidative response of polymorphonuclear neutrophils (PMNs), the relative cell adhesion response of PMNs, and the leukocyte population in tear samples collected from contact lens wearers and non-contact lens wearers. Tear samples were collected via a binocular eye-wash. The samples were processed, and a cell count was performed using a hemacytometer. Flow cytometry was used to determine the expression of different PMN cell markers before and after stimulation with bacterial lipopolysaccharide (LPS).

Conditions

• White Blood Cells

Interventions

Type	Name	Description
DEVICE	Lotrafilcon A contact lens	Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
DEVICE	Lotrafilcon B contact lens	Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
DEVICE	Clear Care Cleaning and Disinfection Solution	Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-06-23
• Last updated: 2013-03-08
• Results posted: 2013-03-08

Locations

1 site across 1 country: Canada