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

Polymorphonuclear Leukocyte Response During Overnight Lens Wear

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01379768

Acronym

CORNWALL

Enrollment

Registered

2011-06-23

Start date

2011-05-31

Completion date

2012-01-31

Last updated

2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Blood Cells

Brief 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).

Interventions

DEVICELotrafilcon A contact lens

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.

DEVICELotrafilcon B contact lens

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.

DEVICEClear Care Cleaning and Disinfection Solution

Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Leukocyte Population	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 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.
Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)	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. 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.
Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)	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. 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).
Change From Week 1 in Leukocyte Population at Week 5	Week 1, 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.
Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5	Week 1, 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.
Change From Week 1 in Relative Oxidative Response of PMNs at Week 5	Week 1, 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.

Countries

Canada

Participant flow

Recruitment details

Study participants were recruited from one study center located in Canada.

Participants by arm

Arm	Count
Lotrafilcon A 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.	23
Lotrafilcon B 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.	22
No Lens Wear 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.	20
Total	65

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	1	1	0
Overall Study	Lost to Follow-up	2	0	0

Baseline characteristics

Characteristic	Lotrafilcon A	Lotrafilcon B	No Lens Wear	Total
Age, Customized	22 years	23.5 years	23.5 years	23 years
Region of Enrollment Canada	23 participants	22 participants	20 participants	65 participants
Sex: Female, Male Female	17 Participants	19 Participants	13 Participants	49 Participants
Sex: Female, Male Male	6 Participants	3 Participants	7 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 23	0 / 22	0 / 20
serious Total, serious adverse events	0 / 23	0 / 22	0 / 20

Outcome results

Primary

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.

Time frame: Week 1, Week 5