Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OmegaD; Placebo
Intervention description: OmegaD Softgels; Placebo Softgels
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the
      treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be
      compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will
      be evaluated for their signs and symptoms of dry eye disease and for safety throughout the
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects age ≥ 18 years and ≤ 90 years on the date of informed consent.

          2. All subjects must provide signed written consent prior to participation in any study
             related procedures.

          3. Patient-reported dry eye symptoms.

          4. Clinical diagnosis of dry eye disease supported by global clinical assessment.

          5. Presence of tear osmolarity in at least one eye ≥ 312 mOsm/L at both Screening and
             Baseline.

          6. Presence of meibomian gland dysfunction as defined by a grade of 1 or 2 on the
             meibomian orifice size scale in at least one eye at both Screening and Baseline. The
             qualifying osmolarity level and meibomian orifice size grade must be present in the
             same eye at both Screening and Baseline if only one eye qualifies.

          7. Female subjects of childbearing potential must have a negative urine pregnancy test at
             Screening. Women of childbearing potential (i.e., women who are not either
             postmenopausal for one year or surgically sterile) must use an acceptable form of
             contraception throughout the study.

        Exclusion Criteria:

          1. Allergy to fish oil or safflower oil (component of placebo softgels) or any component
             of the softgel material.

          2. Schirmer's test score < 5 mm at Screening in either eye.

          3. Tear break-up time > 7 seconds at Screening or Baseline in either eye.

          4. Clinically significant eyelid deformity or eyelid movement disorder that is caused by
             conditions such as notch deformity, incomplete lid closure, entropion, ectropion,
             hordeolum or chalazion.

          5. Active seasonal and/or perennial allergic conjunctivitis or rhinitis.

          6. Previous ocular disease leaving sequelae or requiring current topical eye therapy
             other than for dry eye disease, including, but not limited to: active corneal or
             conjunctival infection of the eye and ocular surface scarring.

          7. History or presence of abnormal nasolacrimal drainage.

          8. Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK)
             performed within one year prior to Screening and throughout the study period.

          9. Ophthalmic drop use within 2 hours prior to any study visit. Any over-the-counter
             (OTC) artificial tear should be continued at the same frequency and with no change in
             drop brand.

         10. Contact lens wear within 12 hours prior to any study visit; subjects determined to
             have worn contact lenses within 12 hours must be rescheduled.

         11. Punctal cauterization or punctal plug placement within 60 days prior to Screening and
             throughout the study period.

         12. Started or changed the dose of systemic medications known to affect tear production
             within 30 days prior to Screening and throughout the study period. These include but
             are not limited to the following medications:

               -  Immunomodulators

               -  Antihistamines

               -  Tricyclic antidepressants

               -  Diuretics

               -  Corticosteroids (intranasal, inhaled, topical dermatological, and perianal
                  steroids are permitted).

         13. Use of any topical prescription ophthalmic medications (including cyclosporine
             [Restasis®, steroids, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-glaucoma
             medications), oral tetracyclines or topical macrolides, oral nutraceuticals [fish,
             flax, black currant seed oils, etc.] within 21 days prior to Screening and throughout
             the study period.

         14. Chronic daily use (defined as > 7 consecutive days at the recommended dosing
             frequency) of oral NSAIDs during the study period. ANY use of oral NSAIDS during the
             study period must be discussed with the Medical Monitor.

         15. Participation in any drug or device clinical investigation within 30 days prior to
             entry into this study and/or during the period of study participation.