Pilot Study of the TearCare System

Inclusion Criteria:

- Dry eye symptoms within 30 months of the screening exam with a SPEED score >=6

- Schirmer 1 value of <010 mm in at least one eye or a Tear Breakup time <10 seconds in
at least one eye

Exclusion Criteria:

- Any active ocular or peri-ocular infection or inflammation

- Recurrent eye inflammation within the past 3 months

- Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes
Zoster

- Ocular surface abnormalities that may affect tear film distribution or treatment

- Abnormal eyelid function in either eye

- Diminished or abnormal facial, periocular, ocular or corneal sensation

- Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal
dystrophies

- Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)

- Allergies to silicone tissue adhesives

- An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).

- Unwillingness to abstain for the duration of the study from systemic medication known
to cause ocular dryness (e.g. Accutane, antihistamines, etc.)

- Anyone who requires chronic use (i.e. for any portion of the study) of topical
ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who
has been on any of these medications within the past 30 days.

- Unwillingness to washout and remain off certain dry eye medications for the duration
of the study.

- Participation in another ophthalmic clinical trial within the past 30 days

- Co-existing conditions that could interfere with the assessment of safety or efficacy
of treatment (e.g. macular disease, pregnancy, nursing, etc.)