The purpose of this study is to measure the relative "barrier" function of the top layer of
the cornea (called the epithelium), or the degree to which the cornea can prevent the
penetration of the colored dye sodium fluorescein into the eye. This is a clinical
investigation of the effect on corneal barrier function following wear of two contact lens
materials and two contact lens care systems, approved for marketing in the US by the Food
and Drug Administration. These contact lenses will be worn for two hours, following soak in
one of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted
contact lens wearers will participate.
- At least 18 years of age.
- Understand your rights as a research subject and give written informed consent
by signing the Informed Consent Form, Subject Bill of Rights, and Patient
Authorization for Use and Release of Health and Research Study Information
- Be likely to finish the entire study, understand the study instructions, and be
willing to follow the instructions.
- Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
- Best correctable visual acuity of at least 20/40 in each eye.
- Willing to de-adapt (do not wear) from habitual contact lenses for periods of
three days prior to barrier function determination.
- Possess a functional spectacle prescription to allow adequate vision during the
de-adaptation and barrier function determination periods.
- No known ocular or systemic allergies, which may interfere with contact lens
- No known systemic disease, or need for medication that may interfere with
contact lens wear (i.e. antihistamines, beta-blockers, steroids).
- Subjects demonstrating any medical condition that may affect the results of this
study SHOULD NOT be enrolled. The following are specific conditions that exclude
subjects from enrollment in this study.
- Eye (ocular) or systemic allergies that may interfere with contact lens wear.
- Less than one month successful, full time (defined as more than 8 hours per day,
and more than 5 days per week) soft lens wear.
- Systemic disease or uses of medication, which may interfere with contact lens
- Clinically significant corneal swelling (greater than grade 3 or 4 on a 0-4
scale), corneal blood vessel growth) (vascularization), corneal staining, bulbar
redness, tarsal redness, or any other abnormality of the cornea that may cause
unsafe contact lens wear.
- Any active ocular infection.
- Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
- Have used medications within 24 hours of study entry or have an ongoing need to
use ocular medication.
- Are taking part in any other study or have taken part in a study within the last
- Have a medical condition that your study eye doctor thinks may make it not
appropriate for you to participate in this study.
- Are pregnant, or anticipate becoming pregnant during the course of this study.