Pilot Study of TearCare System - Long-Term Extension

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.)