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

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01379768
• Collaborator: University of Waterloo (Other)
• Enrollment: 65
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
White Blood Cells	Device: Lotrafilcon A contact lens; Device: Lotrafilcon B contact lens; Device: Clear Care Cleaning and Disinfection Solution	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Polymorphonuclear Leukocyte Response During Overnight Lens Wear
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.; Other Names: AIR OPTIX NIGHT & DAY AQUA ; Device: Clear Care Cleaning and Disinfection Solution; Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses; Other Names: Clear Care®
Active Comparator: 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.	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.; Other Names: NIGHT & DAY® ; Device: Clear Care Cleaning and Disinfection Solution; Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses; Other Names: Clear Care®
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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).

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo Centre for Contact Lens Research	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• CIBA VISION
• University of Waterloo

Investigators

• Principal Investigator: Lyndon Jones, PhD FCOptom FAAO, Director, Centre for Contact Lens Research, School of Optometry, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01379768
• Other Study ID Numbers: P-373-C-102
• First Posted: Jun 23, 2011
• Last Update Posted: Mar 8, 2013
• Last Verified: Mar 1, 2013

Study Results

Participant Flow

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

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	23	22	20
COMPLETED	20	21	20
NOT COMPLETED	3	1	0

Baseline Characteristics

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear	Total
Arm/Group Description	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.	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.	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.	Total of all reporting groups
Overall Participants	23	22	20	65
Age, Customized (years) [Median (Full Range) ]
Median (Full Range) [years]	22	23.5	23.5	23
Sex: Female, Male (Count of Participants)
Female	17 73.9%	19 86.4%	13 65%	49 75.4%
Male	6 26.1%	3 13.6%	7 35%	16 24.6%
Region of Enrollment (participants) [Number]
Canada	23 100%	22 100%	20 100%	65 100%

Outcome Measures

1. Primary Outcome

Title	Leukocyte Population
Description	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.
Time Frame	Week 5

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study per protocol.

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear
Arm/Group Description	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.	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.	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.
Measure Participants	20	19	20
Mean (Standard Deviation) [Leukocytes]	583187 (832636)	420345 (355940)	738140 (609853)

2. Primary Outcome

Title	Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
Description	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.
Time Frame	Week 5

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study per protocol.

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear
Arm/Group Description	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.	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.	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.
Measure Participants	20	18	19
Mean (Standard Deviation) [Ratio]	1.1 (0.2)	1.2 (0.2)	1.1 (0.1)

3. Primary Outcome

Title	Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
Description	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).
Time Frame	Week 5

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study per protocol.

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear
Arm/Group Description	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.	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.	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.
Measure Participants	20	19	20
Mean (Standard Deviation) [Ratio]	1.2 (0.5)	1.7 (1.1)	1.3 (0.6)

4. Primary Outcome

Title	Change From Week 1 in Leukocyte Population at Week 5
Description	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.
Time Frame	Week 1, Week 5

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study per protocol.

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear
Arm/Group Description	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.	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.	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.
Measure Participants	19	19	19
Mean (Standard Deviation) [Leukocytes]	-1377 (453,119)	-95301 (632752)	122316 (519976)

5. Primary Outcome

Title	Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
Description	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

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study per protocol.

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear
Arm/Group Description	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.	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.	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.
Measure Participants	18	15	16
Mean (Standard Deviation) [Ratio]	-0.01 (0.23)	0.00 (0.24)	-0.01 (0.20)

6. Primary Outcome

Title	Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
Description	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.
Time Frame	Week 1, Week 5

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study per protocol.

Arm/Group Title	Lotrafilcon A	Lotrafilcon B	No Lens Wear
Arm/Group Description	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.	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.	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.
Measure Participants	19	18	19
Mean (Standard Deviation) [Ratio]	0.05 (0.94)	0.24 (1.20)	-0.19 (0.58)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study.
Adverse Event Reporting Description	This reporting group includes all enrolled participants.
Arm/Group Title	Lotrafilcon A		Lotrafilcon B		No Lens Wear
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Lotrafilcon A		Lotrafilcon B		No Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon A		Lotrafilcon B		No Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon A		Lotrafilcon B		No Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.