Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers

Study Overview
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Brief Summary
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The purpose of the study is to investigate the corneal epithelial cell response associated with lens wear that results in solution-induced corneal staining (Phase1) and to determine the cell appearance in symptomatic and asymptomatic contact lens wearers (Phase 2).

Detailed Description
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This study consisted of 2 phases. In Phase 1, participants wore contact lenses pre-soaked overnight in contact lens solution for 2 hours and 4 hours, separate days. A minimum of 7 days separated the wear periods. Ocular surface cells were collected after both wear periods. In Phase 2, participants wore their habitual contact lenses on a daily wear basis for 4 weeks with habitual lens care. Ocular surface cells were collected after Day 1 and Day 28. Phase 2 included eligible participants who completed Phase 1 and new participants. A participant was considered to be asymptomatic if he/she can typically wear contact lenses comfortably for at least 10 hours/day a minimum of 5 days/week, and symptomatic if he/she typically wears contact lenses for a minimum of 3 days/week and experiences ocular discomfort after less than 6 hours of wear. Phase 1 participants not eligible to participate in Phase 2 or uninterested in continuing into Phase 2 were exited from the study.

Official Title
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Determination of Cell Population in SICS and Symptomatic Versus Asymptomatic Lens Wearers

Conditions
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Refractive Error, Dry Eye

Intervention / Treatment
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* Device: Balafilcon A contact lens
* Device: Habitual contact lenses
* Device: Renu multi-purpose solution
* Device: ClearCare
* Device: Habitual lens care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Phase 1): Full legal capacity to volunteer. Read and sign an informed consent form. Willing and able to follow instructions and maintain the appointment schedule. Current or previous contact lens wearer and competent to insert and remove contact lenses. Up-to-date spectacles. Other protocol-defined inclusion criteria may apply. Inclusion Criteria (Phase 2): Full legal capacity to volunteer. Read and sign an informed consent form. Willing and able to follow instructions and maintain the appointment schedule. Up-to-date spectacles. Wears single vision silicone hydrogel contact lenses, following a monthly replacement schedule. Has worn the same lens type for a minimum of 2 months, with the exception of the 2 periods of lens wear for participants who were also in Phase 1. Has used the same type of cleaning solution for a minimum of 2 months. Currently wears brand name contact lenses and uses brand name cleaning solutions that are commercially available in Canada (no private labels). Other protocol-defined inclusion criteria may apply. Exclusion Criteria (Phase 1 and 2): Any ocular disease. Systemic condition that may affect a study outcome variable. Use of any systemic or topical medications that may affect ocular health. Known sensitivity to the diagnostic pharmaceuticals to be used in the study. Presents with significant amounts of corneal staining. Current use of artificial tears and/or rewetting drops. Wears contact lenses on an extended (overnight) or continuous wear schedule. 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PV+ClearCare / PV+Renu (Phase 1)<br>Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for two hours and four hours at a time, separate days, with Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in the fellow eye | Device: Balafilcon A contact lens<br>* Commercially marketed silicone hydrogel contact lens<br>* Other names: PureVision™;Device: Renu multi-purpose solution<br>* Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.<br>* Other names: renu® fresh™;Device: ClearCare<br>* Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses<br>* Other names: ClearCare®;|
| Experimental: Habitual (Phase 2)<br>Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care | Device: Habitual contact lenses<br>* Commercially marketed silicone hydrogel contact lenses as prescribed by eye care practitioner, brand and power<br>Device: Habitual lens care<br>* Lens care per habitual use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | The worn contact lenses were removed and epithelial (corneal) cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/ dead stains. The number of viable (alive) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in viable cell count may indicate a physiological response to the contact lens and/or care regimen over time. | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 
| Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable (dead) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in non-viable cell count may indicate a physiological response to the contact lens and/or care regimen over time. | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 
| Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory. The total number of fluorescein-stained cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in fluorescein-stained cell count may indicate a physiological response to the contact lens and/or care regimen over time. | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 
| Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens After 2 Hours and 4 Hours of Wear, Phase 1 | The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from each lens and each eye were counted separately using a microscope. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected. | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 
| Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1 | The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from each lens and each eye were counted separately using a microscope. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated. A higher number indicates a higher percentage of non-viable cells relative to the total cell count. | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 
| Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of viable cells was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age. | Day 1 and Week 4 | 
| Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable cells was counted using a microscope. Cells collected from right and left eyes were pooled.Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age | Day 1 and Week 4 | 
| Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 | The worn contact lenses were removed and transferred into well plates, each containing a soaking solution. Following a soaking duration of approximately 30 minutes, lenses were rinsed and transferred in individual glass vials. The cell content from the lens wash was taken to a laboratory and incubated with live/dead stains. The total number of cells (viable and non-viable) were counted using a microscope. Cells collected from right and left lens were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age. | Day 1 and Week 4 | 
| Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of cells (viable and non-viable) was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age. | Day 1 and Week 4 | 
| Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 | The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected. | Day 1 and Week 4 | 
| Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2 | The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated. A higher number indicates a higher percentage of non-viable cells relative to the total cell count. | Day 1 and Week 4 |