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

NCT01629706 | Completed Results

• 1 other identifier: P-373-C-105
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Refractive Error; Dry Eye

Outcome Measures

Primary Outcomes (11)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

  Day 1 and Week 4

• 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

  Day 1 and Week 4

• 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.

  Day 1 and Week 4

• 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.

  Day 1 and Week 4

• 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.

  Day 1 and Week 4

• 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.

  Day 1 and Week 4

Study Arms (2)

PV+ClearCare / PV+Renu (Phase 1)

EXPERIMENTAL

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; Device: Renu multi-purpose solution; Device: ClearCare

Habitual (Phase 2)

EXPERIMENTAL

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

Device: Habitual contact lenses; Device: Habitual lens care

Interventions

Balafilcon A contact lens DEVICE

Commercially marketed silicone hydrogel contact lens

Also known as: PureVision™

PV+ClearCare / PV+Renu (Phase 1)

Habitual contact lenses DEVICE

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

Habitual (Phase 2)

Renu multi-purpose solution DEVICE

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

Also known as: renu® fresh™

PV+ClearCare / PV+Renu (Phase 1)

ClearCare DEVICE

Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses

Also known as: ClearCare®

PV+ClearCare / PV+Renu (Phase 1)

Habitual lens care DEVICE

Lens care per habitual use

Habitual (Phase 2)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead
• University of Waterloo: collaborator

MeSH Terms

Conditions

Refractive Errors; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Alan Landers, Project Head, Vision Care R&D
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Lyndon Jones, FCOptom, PhD

  University of Waterloo School of Optometry and Vision Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 3, 2015
• Results First Posted: February 13, 2015

Record last verified: 2015-01