Dry Eye Assessment and Management: Feasibility Study

Inclusion Criteria

• Sign and date the informed consent form approved by the IRB.
• ≥ 18 years of age
• Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of randomization).
• Conjunctival staining present ≥ 1
• Corneal fluorescein staining present ≥ 1
• Tear film break up time (TFBUT) ≤ 7 seconds
• Schirmer test ≤ 7 mm/5min
• Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).
• Use or desire to use artificial tears on average of 2 times per day in the 2 weeks preceding study entry (run in period). No newly diagnosed patients can be enrolled and if a new patient wants to participate, she/he must be put on tears and re-evaluated in 6 months.
• Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.
• Women of child-bearing potential must agree to use a reliable method of contraception during study participation, and must demonstrate a negative urine pregnancy test at screening visit.
• Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
• Be able to swallow large, soft gelcaps

Exclusion Criteria

• Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).
• Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
• History of ocular herpetic keratitis.
• Eye surgery (including cataract surgery) within 6 months prior to randomization.
• Previous LASIK surgery
• Pregnant or nursing/lactating
• Participation in a study of an investigational drug or device within the past 30 days.
• Recent (≤ 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation
• Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
• Contact lens wearers
• Use of glaucoma medication or history of surgery for glaucoma.
• Recent (≤ 3 months) insertion of punctual plugs.
• Using punctual plugs but unwilling to commit to their use for the duration of the study.
• Unwilling to commit to same brand of artificial tears throughout the study.
• Current use of EPA/DHA supplements in excess of 1 gram/day.
• Recent (≤ 6 months) initiation of use of Restasis.
• Use of Restasis but unwilling to commit to use of Restasis for the duration of the study.
• Discontinued use of Restasis within the last 3 months.