Study of the TearCare System in Dry Eye Disease

Inclusion Criteria

• At least 22 years of age
• Reports dry eye symptoms within the past 3 months
• Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms.
• OSDI Score of ≥23
• TBUT of ≤7 seconds in both eyes
• Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤15 in each eye.
• At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
• Best spectacle corrected visual acuity of 20/100 or better in both eyes.
• Willing and able to comply with the study procedures and follow-up
• Willing and able to provide informed consent
• English-speaking

Exclusion Criteria

• Any active, clinically significant ocular or peri-ocular infection or inflammation
• Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment
• History of eyelid, conjunctiva or corneal surgery (including refractive surgery) within the past year. In addition, subjects with any history of the following are excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
• Any office-based dry eye treatment (e.g. IPL, thermal pulsation [Lipiflow], etc.) within 12 months prior to enrollment. In addition Blephex or debridement within 3 months prior to enrollment is an exclusion.
• Meibomian gland expression within 6 months prior to enrollment. In addition, any history of meibomian gland probing is an exclusion.
• In the clinical judgement of the investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a sterile cotton swab.
• Contact lens use within the past 2 weeks (Subjects must refrain from wearing contact lenses for the duration of the study.)
• Use of TrueTear device within the past 2 weeks (Subjects must refrain from using the TrueTear device for the duration of the study.)
• History of Ocular Herpes Simplex or Ocular Herpes Zoster
• Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, etc.)
• Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, notching of lid margin, distichiasis, trichiasis)
• Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
• Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area
• Ocular trauma within 3 months prior to enrollment
• Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis
• Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
• Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
• Punctal occlusion or punctal plug placement within 30 days prior to enrollment
• Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.)
• Allergies to silicone tissue adhesives
• Use of Restasis or Xiidra within 60 days prior to enrollment. Subject must also be willing to remain off these drugs for the duration of the study.
• Use of antihistamines (oral or topical) within 10 days prior to enrollment. Subject must also be willing remain off antihistamines for the duration of the study.
• Subject is currently on a systemic medication(s) (other than anti-histamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 d