A Pilot Study of the TearCare System in Adults With Dry Eye Disease

Completed · Not applicable

Conditions studied: Dry Eye

In brief

This is a small, pilot study intended to determine the feasibility of this product.

Key facts

Study ID

NCT03006978

Run by

Sight Sciences, Inc.

People needed

24

Starts

2017-01-01

Expected to finish

2018-03-01

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At Least 18 Years of age
• Reports dry eye symptoms within 3 months of the screening exam with a SPEED score >=6
• Schirmer 1 value of <10 mm in at least one eye or a Tear Breakup time <10 seconds in at least one eye
• Willing to comply with the study, procedures, and follow-up
• Willing and able to provide consent

You may not qualify if…

• 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.)

Where it is running

• Central Eye Care, Ltd. — Arlington Heights, Illinois, United States

Full record on ClinicalTrials.gov

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