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Purpose

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease. NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.

Conditions

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least 22 - Subject has dry eye symptoms and uses artificial tears/lubricants regularly - Subject has moderate to severe symptoms based on a dry eye questionnaire - Subject has an abnormal tear break-up time - Subject's eyelid glands secrete a low amount of meibum - Best corrected visual acuity 20/100 or better - Willing and able to comply with protocol - Willing and able to provide consent - English-speaking

Exclusion Criteria

  • Use of medications that treat dry eye disease or that are known to cause ocular dryness. - Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs - Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing. - History of eyelid, conjunctival or corneal surgery within the past year. - Contact lens use within past 2 weeks - Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TearCare 		Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.
  • Device: TearCare
    The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.
Active Comparator
LipiFlow 		Subjects will have heat and pressure applied to the eyelids for 12 minutes.
  • Device: LipiFlow
    The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
    Other names:
    • Thermal Pulsation

Recruiting Locations

Center for Excellence in Eye Care
Miami, Florida 33176
Contact:
Maria Mugica

More Details

NCT ID
NCT03857919
Status
Recruiting
Sponsor
Sight Sciences, Inc.

Study Contact

Kavita Dhamdhere, MD
877-266-1144
kdhamdhere@sightsciences.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center