Dry Eye Syndrome Clinical Trial
Official title:
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
To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and aqueous tear production in patients with "dry eyes".
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.
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