Study of the TearCare System in Dry Eye Disease

Completed · Not applicable

Conditions studied: Dry Eye

In brief

This study was conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.

Key facts

Study ID

NCT03588624

Run by

Sight Sciences, Inc.

People needed

29

Starts

2018-07-12

Expected to finish

2018-11-08

Last updated by the study team

2025-09-11

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial.
• Subject has taken or is currently taking Accutane
• Subject requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within 30 days prior to enrollment

Where it is running

• Eye Research Institute — Newport Beach, California, United States
• Arlington Eye Physicians — Arlington Heights, Illinois, United States
• Kentucky Eye Institute — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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