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Study of the TearCare System in Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03588624
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sight Sciences, Inc.

Brief Summary:

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

NOTE: All sites have been selected for this study.


Condition or disease Intervention/treatment Phase
Dry Eye Device: TearCare Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the TearCare System in Dry Eye Disease
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: TearCare
All subjects in the study will undergo the TearCare procedure one time at the baseline visit. They will then be followed out to one month.
Device: TearCare
The TearCare procedure includes the delivery of thermal energy to the external surface of the eyelids for 15 minutes, immediately followed by manual expression of each eyelid.




Primary Outcome Measures :
  1. Change in Tear Break-up time from baseline to 1 month [ Time Frame: 1 month ]
    Tear Break-up Time is defined as the number of seconds between a blink and the appearance of a first dry spot or negative staining in the tear film.


Secondary Outcome Measures :
  1. Change in Ocular Surface Disease Index (OSDI) score from baseline to 1 month [ Time Frame: 1 month ]
    The OSDI is a questionnaire that assesses the symptoms of dry eye disease

  2. Change in Meibomian gland secretion score from baseline to 1 month [ Time Frame: 1 month ]
    The is a measure of the quality of the secretions from the meibomian glands

  3. Change in Cornea staining score from baseline to 1 month [ Time Frame: 1 month ]
    This is a measure of the degree of staining on the cornea.

  4. Change in Conjunctival staining score from baseline to 1 month [ Time Frame: 1 month ]
    This is a measure of the degree of staining on the conjunctiva

  5. Device-related adverse events [ Time Frame: 1 month ]
    Any untoward adverse event that is attributed to the study device

  6. Change in best spectacle-corrected visual acuity from baseline to 1 month [ Time Frame: 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with dry eye disease
  • Signs and symptoms of dry eye disease
  • Best corrected visual acuity 20/100 or better
  • Willing and able to comply with study procedures
  • Willing and able to provide consent

Exclusion Criteria:

  • Active ocular infection or inflammation
  • History of eyelid, conjunctiva or corneal surgery within the past year.
  • Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
  • Contact lens wearer
  • Significant ocular surface or eyelid abnormalities, recent ocular trauma
  • Certain corneal surface abnormalities
  • Use of medications for treatment of dry eye or medications that cause dry eye
  • Systemic disease that results in dry eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588624


Contacts
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Contact: Anne Ripley 6616458546 anne@sightsciences.com

Locations
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United States, California
Eye Research Institute Recruiting
Newport Beach, California, United States, 92663
Contact: Yvette Abbascia    949-650-1863    yvette.abbascia@drwirta.com   
United States, Kentucky
Kentucky Eye Institute Recruiting
Lexington, Kentucky, United States, 40517
Contact: Justin Tincher       justin.tincher@kyeye.com   
Sponsors and Collaborators
Sight Sciences, Inc.

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Responsible Party: Sight Sciences, Inc.
ClinicalTrials.gov Identifier: NCT03588624     History of Changes
Other Study ID Numbers: 06001
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases