ABBOTSFORD: Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PV+ClearCare / PV+Renu (Phase 1) 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
Commercially marketed silicone hydrogel contact lens
Other Names:
Device: Renu multi-purpose solution
Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.
Other Names:
Device: ClearCare
Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses
Other Names:
|
| Experimental: Habitual (Phase 2) Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care |
Device: Habitual contact lenses
Commercially marketed silicone hydrogel contact lenses as prescribed by eye care practitioner, brand and power
Device: Habitual lens care
Lens care per habitual use
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CIBA VISION
- University of Waterloo
Investigators
- Principal Investigator: Lyndon Jones, FCOptom, PhD, University of Waterloo School of Optometry and Vision Science
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P-373-C-105
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 1 study center located in Canada. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | PureVision/Habitual |
|---|---|
| Arm/Group Description | Phase 1: 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. Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care. |
| Period Title: Phase 1 PureVision | |
| STARTED | 44 |
| COMPLETED | 35 |
| NOT COMPLETED | 9 |
| Period Title: Phase 1 PureVision | |
| STARTED | 58 |
| COMPLETED | 48 |
| NOT COMPLETED | 10 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | All enrolled participants |
| Overall Participants | 92 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
26.67
(10.79)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
69
75%
|
| Male |
23
25%
|
Outcome Measures
| Title | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 1 of the study with expected in-range responses. |
| Arm/Group Title | PV+ClearCare | PV+Renu |
|---|---|---|
| Arm/Group Description | Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days | Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days |
| Measure Participants | 34 | 34 |
| After 2 hours of wear |
15
(12)
|
20
(23)
|
| After 4 hours of wear |
18
(20)
|
22
(19)
|
| Title | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 1 of the study with expected in-range responses. |
| Arm/Group Title | PV+ClearCare | PV+Renu |
|---|---|---|
| Arm/Group Description | Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days | Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days |
| Measure Participants | 34 | 34 |
| After 2 hours of wear |
654
(392)
|
799
(568)
|
| After 4 hours of wear |
597
(531)
|
896
(498)
|
| Title | Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 1 of the study with expected in-range responses. |
| Arm/Group Title | PV+ClearCare | PV+Renu |
|---|---|---|
| Arm/Group Description | Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days | Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days |
| Measure Participants | 34 | 34 |
| After 2 hours of wear |
25
(27)
|
26
(25)
|
| After 4 hours of wear |
22
(23)
|
27
(22)
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 1 of the study with expected in-range responses. |
| Arm/Group Title | PV+ClearCare | PV+Renu |
|---|---|---|
| Arm/Group Description | Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days | Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days |
| Measure Participants | 34 | 34 |
| After 2 hours of wear |
29.7
(13.9)
|
32.8
(15.8)
|
| After 4 hours of wear |
36.6
(19.2)
|
36.0
(18.0)
|
| Title | Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 1 of the study with expected in-range responses. |
| Arm/Group Title | PV+ClearCare | PV+Renu |
|---|---|---|
| Arm/Group Description | Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days | Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days |
| Measure Participants | 34 | 34 |
| After 2 hours of wear |
96.6
(3.3)
|
97.2
(2.3)
|
| After 4 hours of wear |
95.9
(3.3)
|
96.6
(3.7)
|
| Title | Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 2 of the study with expected in-range responses. |
| Arm/Group Title | Asymptomatic | Symptomatic |
|---|---|---|
| Arm/Group Description | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care |
| Measure Participants | 31 | 17 |
| Day 1 |
58
(43)
|
81
(88)
|
| Week 4 |
52
(41)
|
70
(60)
|
| Title | Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 2 of the study with expected in-range responses. |
| Arm/Group Title | Asymptomatic | Symptomatic |
|---|---|---|
| Arm/Group Description | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care |
| Measure Participants | 31 | 17 |
| Day 1 (n=31,17) |
2712
(1986)
|
3040
(2352)
|
| Week 4 (n=30,17) |
1522
(923)
|
2183
(1822)
|
| Title | Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 2 of the study with expected in-range responses. |
| Arm/Group Title | Asymptomatic | Symptomatic |
|---|---|---|
| Arm/Group Description | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care |
| Measure Participants | 31 | 17 |
| Day 1 (n=31,17) |
2769
(1980)
|
3117
(2383)
|
| Week 4 (n=31,16) |
1574
(939)
|
2253
(1848)
|
| Title | Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 2 of the study with expected in-range responses. |
| Arm/Group Title | Asymptomatic | Symptomatic |
|---|---|---|
| Arm/Group Description | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care |
| Measure Participants | 31 | 17 |
| Day 1 (n=31,17) |
2769
(1980)
|
3117
(2383)
|
| Week 4 (n=30,17) |
1574
(939)
|
2253
(1848)
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 2 of the study with expected in-range responses. |
| Arm/Group Title | Asymptomatic | Symptomatic |
|---|---|---|
| Arm/Group Description | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care |
| Measure Participants | 31 | 17 |
| Day 1 (n=31,17) |
24.8
(14.3)
|
19.5
(10.8)
|
| Week 4 (n=30,16) |
26.8
(11.6)
|
28.7
(14.4)
|
| Title | Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This reporting group included all participants that completed Phase 2 of the study with expected in-range responses. |
| Arm/Group Title | Asymptomatic | Symptomatic |
|---|---|---|
| Arm/Group Description | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care | Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care |
| Measure Participants | 31 | 17 |
| Day 1 (n=31,17) |
97.4
(3.0)
|
97.5
(2.6)
|
| Week 4 (n=30,16) |
97.0
(2.2)
|
96.6
(2.9)
|
Adverse Events
| Time Frame | Adverse events (AEs) were collected for the duration of the study (21 Sep 2012 to 14 Jan 2014). This analysis group includes all participants exposed to study product. 10 people participated in Phase 1 and Phase 2 and were exposed to both products. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | An AE was defined as any undesirable medical occurrence which occurs in an individual participating in a clinical trial, whether or not it is considered to be trial-related. | |||
| Arm/Group Title | PureVision | Habitual | ||
| Arm/Group Description | Balafilcon A contact lenses worn in Phase 1 | Habitual contact lenses worn in Phase 2 | ||
All Cause Mortality |
||||
| PureVision | Habitual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| PureVision | Habitual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | 0/49 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| PureVision | Habitual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | 0/49 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Alan Landers, Project Head, Vision Care R&D |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- P-373-C-105