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: January 31, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 102
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
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
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

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo
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: January 31, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 20, 2014