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

Ciba Vision

Status

Completed

Conditions

Dry Eye

Refractive Error

Treatments

Device: ClearCare

Device: Habitual lens care

Device: Balafilcon A contact lens

Device: Habitual contact lenses

Device: Renu multi-purpose solution

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01629706

P-373-C-105

Details and patient eligibility

About

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).

Full 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.

Enrollment

92 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

92 participants in 2 patient groups

PV+ClearCare / PV+Renu (Phase 1)

Experimental group

Description:

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

Treatment: