Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity

Inclusion Criteria:

- Dry eye patients with Level 2 disease or greater as defined by the Delpi Panel

- Tear osmolarity of at least 308 mosm

- At least 18 years of age, Male or Female

- Willing to provide written informed consent

- Likely to complete all study visits

- If currently using ocular lubricants, must complete a 10-14 day washout

Exclusion Criteria:

- Presence of any active ocular disease other than dry eye

- Use of topical ophthalmic medications

- Use of contact lenses during the trial

- Pregnant or nursing, or planning a pregnancy. Patients will be asked if they are
pregnant or may be pregnant and excluded if they answer in the affirmative.

- Any known sensitivity to any ingredients of either study drop

- Oral anti-inflammatory medications, omega 3 supplements, or doxycycline

- Punctal plugs inserted within the last 6 months or less

- Uncontrolled systemic disease

- Subjects with known sensitivity or inappropriate responsiveness to any of the
medications used.

- Acute or chronic disease or illness that would increase risk or confound study
results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)

- Corneal abnormalities (e.g., ecstatic diseases, degenerations, or corneal dystrophies
of the stroma or endothelium)

- Concurrent participation or participation in the last 30 days in any other clinical
trial