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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Polymorphonuclear Leukocyte Response During Overnight Lens Wear

Conditions
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White Blood Cells

Intervention / Treatment
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* Device: Lotrafilcon A contact lens
* Device: Lotrafilcon B contact lens
* Device: Clear Care Cleaning and Disinfection Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 17 years of age or older. Ocular examination in the last two years. Has up-to-date spectacles. Falls into one of the following three categories: Adapted wearer of Lotrafilcon A contact lenses Adapted wearer of Lotrafilcon B contact lenses Does not wear contact lenses Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Ocular disease Systemic or topical medications that may affect ocular health. Known sensitivity to diagnostic pharmaceuticals used in study. Uses artificial tears and/or rewetting drops. Wears contact lenses on an overnight basis for more than one night per week. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lotrafilcon A<br>Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear. | Device: Lotrafilcon A contact lens<br>* Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.<br>* Other names: AIR OPTIX NIGHT & DAY AQUA;Device: Clear Care Cleaning and Disinfection Solution<br>* Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses<br>* Other names: Clear Care®;|
| Active Comparator: Lotrafilcon B<br>Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear. | Device: Lotrafilcon B contact lens<br>* Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.<br>* Other names: NIGHT & DAY®;Device: Clear Care Cleaning and Disinfection Solution<br>* Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses<br>* Other names: Clear Care®;|
| No Intervention: No lens wear<br>No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte Population | A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response. | Week 5 | 
| Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs) | A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples. | Week 5 | 
| Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs) | A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated). | Week 5 | 
| Change From Week 1 in Leukocyte Population at Week 5 | A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented. | Week 1, Week 5 | 
| Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5 | A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented. | Week 1, Week 5 | 
| Change From Week 1 in Relative Oxidative Response of PMNs at Week 5 | A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented. | Week 1, Week 5 |