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Study of the TearCare System in Dry Eye Disease

Sponsor
Sight Sciences, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03588624
Collaborator
(none)
30
Enrollment
2
Locations
1
Arm
1.7
Anticipated Duration (Months)
15
Patients Per Site
9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: TearCare
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
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 :
Jul 12, 2018
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Tear Break-up time from baseline to 1 month [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 [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 [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 [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 [1 month]

    This is a measure of the degree of staining on the conjunctiva

  5. Device-related adverse events [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 [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Research Institute Newport Beach California United States 92663
2 Kentucky Eye Institute Lexington Kentucky United States 40517

Sponsors and Collaborators

  • Sight Sciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sight Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT03588624
Other Study ID Numbers:
  • 06001
First Posted:
Jul 17, 2018
Last Update Posted:
Aug 17, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases

Study Results

No Results Posted as of Aug 17, 2018