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