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

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.

Inclusion Criteria: Patient over 18 years of age, patient willing and able to comply with
the protocol, no planned changes in diet, topical or systemic drugs during course of study.
Ocular symptoms consistent with dry eye of insidious onset and greater than three months
duration. Ocular surface vital staining consistent with aqueous deficient dry eyes with
less than +1 conjunctival injection and no more than minimal lid inflammation -

Exclusion Criteria: Any patient that uses topical eye drops other than artificial tears.
Any patient with punctual occlusion or punctual plugs. Patients with active ocular
infection or inflammatory disease, history of herpetic keratitis, history of retinal
detachment, concurrent contact lens use during the trial period, ocular surgery within the
past six months, patients with glaucoma, anterior membrane dystrophy, active trichiasis or
any eyelid globe malposition abnormality, e.g., entropion, ectropion, etc. Patients with
Epiphora (excessive tearing). Moreover, patients taking medications known to effect aqueous
tear production or meibomian secretions. Patient must not have participated in (or be
currently participating in) any investigational therapeutic drug or device trial within the
previous 30 days prior to their start date for this trial. In addition, any patient
suffering from organic brain syndromes or major psychiatric disorder that would interfere
with compliance or subjective reporting will be discouraged from participating in this
trial.