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

This study has been completed.
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01629706
First received: June 26, 2012
Last updated: February 12, 2015
Last verified: January 2015
  Purpose

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 Intervention
Refractive Error
Dry Eye
Device: Balafilcon A contact lens
Device: Habitual contact lenses
Device: Renu multi-purpose solution
Device: ClearCare
Device: Habitual lens care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Determination of Cell Population in SICS and Symptomatic Versus Asymptomatic Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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 [ Time Frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 after 2 hours of wear; Day 7 after 4 hours of wear ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 1 and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 and Week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 92
Study Start Date: September 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PureVision™
Device: Renu multi-purpose solution
Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.
Other Name: renu® fresh™
Device: ClearCare
Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses
Other Name: ClearCare®
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

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629706

Sponsors and Collaborators
CIBA VISION
University of Waterloo
Investigators
Principal Investigator: Lyndon Jones, FCOptom, PhD University of Waterloo School of Optometry and Vision Science
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01629706     History of Changes
Other Study ID Numbers: P-373-C-105
Study First Received: June 26, 2012
Results First Received: January 29, 2015
Last Updated: February 12, 2015
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 03, 2015