White Blood CellsCORNWALLNCT01379768
Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
A study testing Lotrafilcon A contact lens, Lotrafilcon B contact lens and Clear Care Cleaning and Disinfection Solution in people with White Blood Cells, run by CIBA VISION at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- White Blood Cells
- What is being tested?
- Lotrafilcon A contact lens, Lotrafilcon B contact lens and Clear Care Cleaning and Disinfection Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Waterloo Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1
About this study
Official title: Polymorphonuclear Leukocyte Response During Overnight Lens Wear
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.
Read the 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
- Being tested
- Lotrafilcon A contact lens, Lotrafilcon B contact lens, Clear Care Cleaning and Disinfection Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon A contact lensDevice
Also called AIR OPTIX NIGHT & DAY AQUA
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
Lotrafilcon B contact lensDevice
Also called NIGHT & DAY®
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Clear Care Cleaning and Disinfection SolutionDevice
Also called Clear Care®
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon A | Active comparator | 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. Receives: Device: Lotrafilcon A contact lens; Device: Clear Care Cleaning and Disinfection Solution |
| Lotrafilcon B | Active comparator | 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. Receives: Device: Lotrafilcon B contact lens; Device: Clear Care Cleaning and Disinfection Solution |
| No lens wear | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for White Blood CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD FCOptom FAAO, Director, Principal investigator, Centre for Contact Lens Research, School of Optometry, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379768
- Sponsor's protocol ID
- P-373-C-102
- Acronym
- CORNWALL
- Status last verified
- Mar 2013
- First submitted
- 9 Jun 2011
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphonuclear Leukocyte Response During Overnight Lens Wear
- ClinicalTrials.gov ID
- NCT01379768
- Acronym / sponsor ID
- CORNWALL / P-373-C-102
- Conditions
- White Blood Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- May 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon A | Active comparator | Device: Lotrafilcon A contact lens, Device: Clear Care Cleaning and Disinfection SolutionLotrafilcon 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 | Active comparator | Device: Lotrafilcon B contact lens, Device: Clear Care Cleaning and Disinfection SolutionLotrafilcon 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 lens wear | No intervention | –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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lotrafilcon A contact lensAlso: AIR OPTIX NIGHT & DAY AQUACommercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights. | Device | Lotrafilcon A |
| Lotrafilcon B contact lensAlso: NIGHT & DAY®Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights. | Device | Lotrafilcon B |
| Clear Care Cleaning and Disinfection SolutionAlso: Clear Care®Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses | Device | Lotrafilcon A, Lotrafilcon B |
Primary outcome
Leukocyte Population
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Jones, PhD FCOptom FAAO, Director principal investigator
Centre for Contact Lens Research, School of Optometry, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon A contact lens, Lotrafilcon B contact lens and Clear Care Cleaning and Disinfection Solution in people with White Blood Cells, run by CIBA VISION at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocyte Population (time frame: Week 5). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.