Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear

This investigation will evaluate corneal staining and epithelial barrier function after eight
hours of contact lens wear, which is past the peak staining time and more typical of daily
lens wear time. A silicone hydrogel lens and multipurpose solution combination shown to
induce significant corneal staining ( e.g. equivalent Grade 3 out of Grade 4 scale) will be
used to evaluate potential corneal compromise. The study will be a prospective,
single-center, double-masked, contralateral, daily wear investigation in adapted soft contact
lens wearers. After a three day washout period (without lens wear, lenses will then be worn
on one day for eight hours. Corneal staining and barrier function will be determined for a
regimen and a saline control situation for each subject. Staining will be graded using the
Efron Grading Scale, and permeability data will be estimated as the fluorescein penetration
rate, Pdc in nm/sec for the test and control condition.

Inclusion Criteria:

- 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 (HIPAA form).

- 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 a period of at
least two days prior to eligibility visit and at least two days prior to the testing
day.

- Possess a functional spectacle (eyeglass) prescription to allow adequate vision during
the de-adaptation and barrier function determination periods.

- No known allergies, which may interfere with contact lens wear.

- No known systemic (pertaining to general health) disease, or need for medication that
may interfere with contact lens wear (i.e. antihistamines, beta-blockers, steroids).

Exclusion Criteria:

- Less than one month successful, full time (defined as at least 8 hours per day, and
more than 5 days per week) soft lens wear.

- 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 14
days

- 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.