A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional

Summary: 
      To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and
      aqueous tear production in patients with "dry eyes".
    

Detailed description: 
      The effects of essential fatty acids on Meibomian Gland lipid composition and aqueous tear
      production may be greater than previously thought. Dry Eye syndromes afflict millions of
      people worldwide, more than 10 million in the United States alone. Typically, symptoms that
      are associated with dry eye disease include ocular burning, foreign body sensation,
      photophobia and other symptoms that result in overall chronic discomfort in patients.
      Unfortunately, the effects of Essential Fatty Acids on aqueous tears or Meibomian lipids (AT)
      have not been established to date. The purpose of this study is to better understand the role
      essential fatty acids play in the maintenance of meibomian gland lipids and overall
      production or retention of aqueous tears.

      Patients diagnosed with dry eye syndrome will be selected to participate in the study. Once
      qualified to take part in the trial, participants randomized to the active comparator arm
      will receive four oral doses of soft-gel capsules to be taken daily (QD). Omega-3 Fatty Acid
      daily content:

      EPA (eicosapentaenoic acid) Dose: 450mg DHA (docosahexaenoic acid) Dose: 300mg Flaxseed Oil
      (organic) Dose: 1000mg

      Patients on placebo will receive nutritional supplement capsules containing wheat germ oil
      but no EFA's. During the trial, patient will be encouraged not to change their diet, use of
      topical ophthalmics and systemic therapies other than the use of study treatment. Patient's
      topical therapy will be standardized after identification exam so that all patients will use
      TheraTears™ four times daily. Patients will be directed to take the masked capsules in the
      following manner: 4 soft-gels in the morning.

      Masked medication, TheraTears™ and randomization tables will be provided by sponsor.

      Subject will have the following tests performed during the first visit (before initiating
      treatment) and follow-up (after three months of treatment) visit,: a complete eye exam,
      (vital staining of ocular surface and tear break-up time); completion of questionnaires:
      Ocular Surface Index (OSDI) and Patient Symptomology Questionnaire will be presented to the
      patient to review and answer at both visits: Before initiating treatment and after three
      months on therapy, meibography, fluorophotometry will be performed in order to measure tear
      volume, flow and turnover, Schirmer test; and tear evaporation using an evaporimeter;
      meibomian gland drop out determined by infrared photography and meibomian gland secretion for
      biochemical analysis.
    

Intervention name(s): Omega-3 fatty acid supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants receive four oral doses of soft-gel capsules to be taken daily (QD) for 3 months.; Participants receive four oral doses of soft-gel capsules containing wheat germ oil to be taken daily for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to receive either omega-3 fatty acid or placebo soft-gel capsules.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meibomian Gland Syndrome; Blepharitis