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

NCT ID: NCT01629706

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-01-31

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.

Conditions

Refractive Error; Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Balafilcon A contact lens

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens

Renu multi-purpose solution

Intervention Type: DEVICE

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

ClearCare

Intervention Type: DEVICE

Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses

Habitual (Phase 2)

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

Group Type: EXPERIMENTAL

Habitual contact lenses

Intervention Type: DEVICE

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

Habitual lens care

Intervention Type: DEVICE

Lens care per habitual use

Interventions

Balafilcon A contact lens

Commercially marketed silicone hydrogel contact lens

Intervention Type: DEVICE

Habitual contact lenses

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

Intervention Type: DEVICE

Renu multi-purpose solution

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

Intervention Type: DEVICE

ClearCare

Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses

Intervention Type: DEVICE

Habitual lens care

Lens care per habitual use

Intervention Type: DEVICE

Other Intervention Names

PureVision™; renu® fresh™; ClearCare®

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Waterloo

OTHER

Sponsor Role: collaborator

CIBA VISION

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, FCOptom, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo School of Optometry and Vision Science

Other Identifiers

P-373-C-105

Identifier Type: -

Identifier Source: org_study_id