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

This study is currently recruiting participants.
Verified May 2013 by Alcon Research
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: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to investigate solution-induced corneal staining by closely examining the activity and appearance of cells on the surface of the eye after contact lens wear.


Condition Intervention
Myopia
Dry Eye
 Device: Balafilcon A contact lens (PureVision)
Device: Habitual contact lenses
Device: renu fresh multi-purpose solution
Device: Clear Care cleaning and disinfecting system
Device: Habitual lens care system

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

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Number of Viable Epithelial Cells, Phase 1 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Number of Non-Viable Epithelial Cells, Phase 1 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Number of Fluorescein-Stained Cells, Phase 1 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Number of Viable Epithelial Cells, Phase 1 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Number of Non-Viable Epithelial Cells, Phase 1 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Number of Fluorescein-Stained Cells, Phase 1 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Number of Viable Epithelial Cells, Phase 2 [ Time Frame: Day 1, 8 hours ] [ Designated as safety issue: No ]
  • Number of Non-Viable Epithelial Cells, Phase 2 [ Time Frame: Day 1, 8 hours ] [ Designated as safety issue: No ]
  • Number of Epithelial Cells Collected from the Ocular Surface, Phase 2 [ Time Frame: Day 1, 8 hours ] [ Designated as safety issue: No ]
  • Number of Epithelial Cells Collected from the Contact Lens, Phase 2 [ Time Frame: Day 1, 8 hours ] [ Designated as safety issue: No ]
  • Number of Viable Epithelial Cells, Phase 2 [ Time Frame: Day 28, 8 hours ] [ Designated as safety issue: No ]
  • Number of Non-Viable Epithelial Cells, Phase 2 [ Time Frame: Day 28, 8 hours ] [ Designated as safety issue: No ]
  • Number of Epithelial Cells Collected from the Ocular Surface, Phase 2 [ Time Frame: Day 28, 8 hours ] [ Designated as safety issue: No ]
  • Number of Epithelial Cells Collected from the Contact Lens, Phase 2 [ Time Frame: Day 28, 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PureVision with renu / PureVision with Clear Care
Phase 1: PureVision contact lens pre-soaked overnight in renu multi-purpose solution randomly assigned to one eye, with PureVision contact lens pre-soaked overnight in Clear Care cleaning and disinfecting solution in the fellow eye for contralateral wear.
 Device: Balafilcon A contact lens (PureVision)
Commercially marketed silicone hydrogel contact lens
Other Name: PureVision™
Device: renu fresh multi-purpose solution
Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.
Other Name: renu® fresh™
Device: Clear Care cleaning and disinfecting system
Commercially marketed 3% hydrogen peroxide solution system for cleaning and disinfecting contact lenses
Other Name: Clear Care®
Habitual contact lenses / habitual lens care system
Phase 2: Habitual silicone hydrogel contact lenses worn bilaterally on a daily wear basis, minimum 5 days per week, for 4 weeks, with habitual lens care system.
 Device: Habitual contact lenses
Commercially marketed silicone hydrogel contact lenses as prescribed by eye care practitioner, brand and power
Device: Habitual lens care system
Lens care system per habitual use

  Eligibility

Ages Eligible for Study:   17 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Phase 1):

  • 17 years of age or older with full legal capacity to volunteer.
  • Willing and able to follow instructions and maintain the appointment schedule.
  • Ocular examination within the last two years.
  • Current or previous contact lens wear and competent to insert and remove contact lenses.
  • Up-to-date spectacles.
  • Other protocol-defined inclusion criteria may apply.

Inclusion Criteria (Phase 2):

  • 17 years of age or older with full legal capacity to volunteer.
  • Willing and able to follow instructions and maintain the appointment schedule.
  • Ocular examination within the last two years.
  • Wears single vision silicone hydrogel contact lenses, following a monthly replacement schedule.
  • Has worn the same lens type for a minimum of two months, with the exception of the two periods of lens wear for participants who were also in Phase 1.
  • Has used the same type of cleaning solution for a minimum of two 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629706

Contacts
Contact: Kathy Dumbleton, MSc McOptom FAAO 1-519-888-4567 ext 32694 kdumble@uwaterloo.ca

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
University of Waterloo
Investigators
Principal Investigator: Lyndon Jones, FCOptom, PhD Centre for Contact Lens Research, School of Optometry, University of Waterloo
  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
Last Updated: May 2, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013