Pilot Study of TearCare System - Long-Term Extension

Completed · Not applicable

Conditions studied: Dry Eye Syndromes

In brief

The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.

Key facts

Study ID

NCT03804502

Run by

Sight Sciences, Inc.

People needed

12

Starts

2018-12-17

Expected to finish

2019-05-21

Last updated by the study team

2025-10-28

Who can join

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

You may qualify if…

• Previously enrolled in the TearCare arm of the TearCare Pilot Study
• Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
• TBUT of <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 — Arlington Heights, Illinois, United States

Full record on ClinicalTrials.gov

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