Trial Outcomes & Findings for Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers (NCT NCT01629706)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

Day 1 after 2 hours of wear; Day 7 after 4 hours of wear

Results posted on

2015-03-03

Participant Flow

Participants were recruited from 1 study center located in Canada.

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.

Participant milestones

Participant milestones
Measure	PureVision/Habitual 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.
Phase 1 PureVision STARTED	44
Phase 1 PureVision COMPLETED	35
Phase 1 PureVision NOT COMPLETED	9
Phase 2 Habitual STARTED	58
Phase 2 Habitual COMPLETED	48
Phase 2 Habitual NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	PureVision/Habitual 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.
Phase 1 PureVision Screen Failure	4
Phase 1 PureVision Slit Lamp Finding prior to Dispense	1
Phase 1 PureVision Inconvenience prior to Dispense	1
Phase 1 PureVision No Solution-Induced Corneal Staining	3
Phase 2 Habitual Screen Failure	6
Phase 2 Habitual Slit Lamp Finding prior to Dispense	1
Phase 2 Habitual Relocation prior to Dispense	1
Phase 2 Habitual Lost to Follow Up prior to Dispense	1
Phase 2 Habitual Lost to Follow Up after Dispense	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=92 Participants All enrolled participants
Age, Continuous	26.67 years STANDARD_DEVIATION 10.79 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PV+ClearCare n=34 Participants 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	PV+Renu n=34 Participants Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
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	20 cells Standard Deviation 23
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	22 cells Standard Deviation 19

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PV+ClearCare n=34 Participants 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	PV+Renu n=34 Participants Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
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	799 cells Standard Deviation 568
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	896 cells Standard Deviation 498

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PV+ClearCare n=34 Participants 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	PV+Renu n=34 Participants Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
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	26 cells Standard Deviation 25
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	27 cells Standard Deviation 22

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PV+ClearCare n=34 Participants 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	PV+Renu n=34 Participants Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
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	32.8 percentage of cells Standard Deviation 15.8
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	36.0 percentage of cells Standard Deviation 18.0

PRIMARY outcome

Timeframe: 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.

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.