TearCare System to Treat Dry Eye Disease

The primary objective of this study was to demonstrate the safety and effectiveness of a single TearCare System treatment compared to a single LipiFlow treatment in relieving the signs and symptoms of dry eye disease. This study was conducted to collect data to support a modification to the TearCare indication for use to read as follows, "The TearCare® System is indicated for the treatment of the signs and symptoms of dry eye disease (DED)."

Key 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 23-79
• TBUT of ≤7 seconds in both eyes
• Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
• At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
• Best 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

Key Exclusion Criteria:

• Use of any of the following medications:

• Restasis or Xiidra within 60 days prior to enrollment;
• Antihistamines (oral or topical) within 10 days prior to enrollment;
• 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 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
• Accutane (at any time);
• Oral tetracyclines or azithromycin within 30 days prior to enrollment; or
• Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to enrollment.

NOTE: Use of any of the above medications (with the exception of 1c) is not permitted during the 1 month follow-up period.

• Any of the following dry eye treatments:

• Office-based dry eye treatment (e.g. IPL, thermal pulsation [Lipiflow], etc.) within 12 months prior to enrollment;
• Meibomian gland expression within 6 months prior to enrollment;
• Blephex or debridement within 3 months prior to enrollment is an exclusion;
• Punctal occlusion or punctal plug placement within 30 days prior to enrollment;
• Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or
• Any history of meibomian gland probing
• 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.
• Contact lens use within the past 2 weeks. (Subjects must refrain from wearing contact lenses during the 1-month follow-up.)
• History of Ocular Herpes Simplex or Ocular Herpes Zoster
• 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
• Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
• Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
• Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.
• 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.
• Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, Salzmann's nodules, etc.)
• Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
• Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis.
• Ocular trauma within 3 months prior to enrollment.
• Known history of diminished or abnormal facial, periocular, ocular or corneal sensation
• Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.)
• Subject is currently using Retin A or Latisse.
• Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.
• Subject is currently using Lash Boost.
• Allergies to silicone tissue adhesives
• Participation in another ophthalmic clinical trial within one year prior to enrollment. Subject must also be willing to refrain from another ophthalmic study for the duration of the study.
• Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol. For example, subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.