Back to results

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

Primary Purpose

Refractive Error, Dry Eye

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Balafilcon A contact lens

Habitual contact lenses

Renu multi-purpose solution

ClearCare

Habitual lens care

About this trial

This is an interventional basic science trial for Refractive Error

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PV+ClearCare / PV+Renu (Phase 1)

Habitual (Phase 2)

Arm Description

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

Outcomes

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

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

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

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

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

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

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

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

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

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01629706

First Posted

June 26, 2012

Last Updated

February 12, 2015

Sponsor

CIBA VISION

Collaborators

University of Waterloo

1. Study Identification

Unique Protocol Identification Number

NCT01629706

Brief Title

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

Acronym

ABBOTSFORD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CIBA VISION

Collaborators

University of Waterloo

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Error, Dry Eye

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PV+ClearCare / PV+Renu (Phase 1)

Arm Type

Experimental

Arm Description

Arm Title

Habitual (Phase 2)

Arm Type

Experimental

Arm Description

Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care

Intervention Type

Device

Intervention Name(s)

Balafilcon A contact lens

Other Intervention Name(s)

PureVision™

Intervention Description

Commercially marketed silicone hydrogel contact lens

Intervention Type

Device

Intervention Name(s)

Habitual contact lenses

Intervention Description

Commercially marketed silicone hydrogel contact lenses as prescribed by eye care practitioner, brand and power

Intervention Type

Device

Intervention Name(s)

Renu multi-purpose solution

Other Intervention Name(s)

renu® fresh™

Intervention Description

Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.

Intervention Type

Device

Intervention Name(s)

ClearCare

Other Intervention Name(s)

ClearCare®

Intervention Description

Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses

Intervention Type

Device

Intervention Name(s)

Habitual lens care

Intervention Description

Lens care per habitual use

Primary Outcome Measure Information:

Title

Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1

Description

Time Frame