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

Not Applicable

Completed

Conditions: Dry Eye
Refractive Error

Interventions: Device: Balafilcon A contact lens
Device: Habitual contact lenses
Device: Renu multi-purpose solution
Device: Habitual lens care
Device: ClearCare

Registration Number: NCT01629706

Lead Sponsor: CIBA VISION

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PV+ClearCare / PV+Renu (Phase 1)	ClearCare	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
PV+ClearCare / PV+Renu (Phase 1)	Balafilcon A contact lens	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
PV+ClearCare / PV+Renu (Phase 1)	Renu multi-purpose solution	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
Habitual (Phase 2)	Habitual contact lenses	Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
Habitual (Phase 2)	Habitual lens care	Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care

Primary Outcome Measures

Name	Time	Method
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 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 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 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 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.
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.
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.
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 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 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.