Refractive Error, Dry Eye
Conditions
Brief summary
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
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.
Interventions
Commercially marketed silicone hydrogel contact lens
DEVICEHabitual contact lenses
Commercially marketed silicone hydrogel contact lenses as prescribed by eye care practitioner, brand and power
DEVICERenu multi-purpose solution
Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.
DEVICEClearCare
Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses
DEVICEHabitual lens care
Lens care per habitual use
Sponsors
University of Waterloo
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 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. |
| Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 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. |
| Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 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. |
| 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 | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 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. |
| Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1 | Day 1 after 2 hours of wear; Day 7 after 4 hours of wear | 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. |
| Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 and Week 4 | 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. |
| Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 and Week 4 | 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 |
| Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 | Day 1 and Week 4 | 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. |
| Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 and Week 4 | 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. |
| 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 | Day 1 and Week 4 | 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. |
| Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2 | Day 1 and Week 4 | 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. |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in Canada.
Pre-assignment details
A total of 92 unique participants were enrolled in the study, 44 in Phase 1 and 48 in Phase 2. Additionally, Phase 2 enrolled 10 participants from Phase 1, for a total of 58 participants in this Phase.
Participants by arm
| Arm | Count |
|---|---|
| Overall All enrolled participants | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Phase 1 PureVision | Inconvenience prior to Dispense | 1 |
| Phase 1 PureVision | No Solution-Induced Corneal Staining | 3 |
| Phase 1 PureVision | Screen Failure | 4 |
| Phase 1 PureVision | Slit Lamp Finding prior to Dispense | 1 |
| Phase 2 Habitual | Lost to Follow Up after Dispense | 1 |
| Phase 2 Habitual | Lost to Follow Up prior to Dispense | 1 |
| Phase 2 Habitual | Relocation prior to Dispense | 1 |
| Phase 2 Habitual | Screen Failure | 6 |
| Phase 2 Habitual | Slit Lamp Finding prior to Dispense | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 26.67 years STANDARD_DEVIATION 10.79 |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 49 |
| serious Total, serious adverse events | 0 / 38 | 0 / 49 |
Outcome results
Primary
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.
Time frame: Day 1 and Week 4
Population: This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 2769 cells | Standard Deviation 1980 |
| PV+ClearCare | Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Week 4 (n=30,17) | 1574 cells | Standard Deviation 939 |
| PV+Renu | Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 3117 cells | Standard Deviation 2383 |
| PV+Renu | Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Week 4 (n=30,17) | 2253 cells | Standard Deviation 1848 |
Primary
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.
Time frame: Day 1 and Week 4
Population: This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 2769 cells | Standard Deviation 1980 |
| PV+ClearCare | Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 | Week 4 (n=31,16) | 1574 cells | Standard Deviation 939 |
| PV+Renu | Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 3117 cells | Standard Deviation 2383 |
| PV+Renu | Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 | Week 4 (n=31,16) | 2253 cells | Standard Deviation 1848 |
Primary
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.
Time frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
Population: This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 25 cells | Standard Deviation 27 |
| PV+ClearCare | Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 22 cells | Standard Deviation 23 |
| PV+Renu | Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 26 cells | Standard Deviation 25 |
| PV+Renu | Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 27 cells | Standard Deviation 22 |
Primary
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.
Time frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
Population: This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 654 cells | Standard Deviation 392 |
| PV+ClearCare | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 597 cells | Standard Deviation 531 |
| PV+Renu | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 799 cells | Standard Deviation 568 |
| PV+Renu | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 896 cells | Standard Deviation 498 |
Primary
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
Time frame: Day 1 and Week 4
Population: This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 2712 cells | Standard Deviation 1986 |
| PV+ClearCare | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Week 4 (n=30,17) | 1522 cells | Standard Deviation 923 |
| PV+Renu | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 3040 cells | Standard Deviation 2352 |
| PV+Renu | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Week 4 (n=30,17) | 2183 cells | Standard Deviation 1822 |
Primary
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.
Time frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
Population: This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 15 cells | Standard Deviation 12 |
| PV+ClearCare | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 18 cells | Standard Deviation 20 |
| PV+Renu | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 20 cells | Standard Deviation 23 |
| PV+Renu | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 22 cells | Standard Deviation 19 |
Primary
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.
Time frame: Day 1 and Week 4
Population: This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 | 58 cells | Standard Deviation 43 |
| PV+ClearCare | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Week 4 | 52 cells | Standard Deviation 41 |
| PV+Renu | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Day 1 | 81 cells | Standard Deviation 88 |
| PV+Renu | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 | Week 4 | 70 cells | Standard Deviation 60 |
Primary
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.
Time frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
Population: This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | 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 | After 2 hours of wear | 29.7 percentage of cells | Standard Deviation 13.9 |
| PV+ClearCare | 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 | After 4 hours of wear | 36.6 percentage of cells | Standard Deviation 19.2 |
| PV+Renu | 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 | After 2 hours of wear | 32.8 percentage of cells | Standard Deviation 15.8 |
| PV+Renu | 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 | After 4 hours of wear | 36.0 percentage of cells | Standard Deviation 18 |
Primary
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.
Time frame: Day 1 and Week 4
Population: This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | 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 | Day 1 (n=31,17) | 24.8 percentage of cells | Standard Deviation 14.3 |
| PV+ClearCare | 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 | Week 4 (n=30,16) | 26.8 percentage of cells | Standard Deviation 11.6 |
| PV+Renu | 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 | Day 1 (n=31,17) | 19.5 percentage of cells | Standard Deviation 10.8 |
| PV+Renu | 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 | Week 4 (n=30,16) | 28.7 percentage of cells | Standard Deviation 14.4 |
Primary
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.
Time frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear
Population: This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 96.6 percentage of cells | Standard Deviation 3.3 |
| PV+ClearCare | Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 95.9 percentage of cells | Standard Deviation 3.3 |
| PV+Renu | Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1 | After 2 hours of wear | 97.2 percentage of cells | Standard Deviation 2.3 |
| PV+Renu | Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1 | After 4 hours of wear | 96.6 percentage of cells | Standard Deviation 3.7 |
Primary
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.
Time frame: Day 1 and Week 4
Population: This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PV+ClearCare | Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 97.4 percentage of cells | Standard Deviation 3 |
| PV+ClearCare | Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2 | Week 4 (n=30,16) | 97.0 percentage of cells | Standard Deviation 2.2 |
| PV+Renu | Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2 | Day 1 (n=31,17) | 97.5 percentage of cells | Standard Deviation 2.6 |
| PV+Renu | Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2 | Week 4 (n=30,16) | 96.6 percentage of cells | Standard Deviation 2.9 |