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Study of the TearCare System in Dry Eye Disease

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TearCare
Sponsored by
Sight Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Research InstituteRecruiting
  • Kentucky Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TearCare

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Tear Break-up time from baseline to 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

Change in Ocular Surface Disease Index (OSDI) score from baseline to 1 month
The OSDI is a questionnaire that assesses the symptoms of dry eye disease
Change in Meibomian gland secretion score from baseline to 1 month
The is a measure of the quality of the secretions from the meibomian glands
Change in Cornea staining score from baseline to 1 month
This is a measure of the degree of staining on the cornea.
Change in Conjunctival staining score from baseline to 1 month
This is a measure of the degree of staining on the conjunctiva
Device-related adverse events
Any untoward adverse event that is attributed to the study device
Change in best spectacle-corrected visual acuity from baseline to 1 month

Full Information

First Posted
July 3, 2018
Last Updated
August 15, 2018
Sponsor
Sight Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03588624
Brief Title
Study of the TearCare System in Dry Eye Disease
Official Title
Study of the TearCare System in Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sight Sciences, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TearCare
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TearCare
Intervention Description
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 Measure Information:
Title
Change in Tear Break-up time from baseline to 1 month
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI) score from baseline to 1 month
Description
The OSDI is a questionnaire that assesses the symptoms of dry eye disease
Time Frame
1 month
Title
Change in Meibomian gland secretion score from baseline to 1 month
Description
The is a measure of the quality of the secretions from the meibomian glands
Time Frame
1 month
Title
Change in Cornea staining score from baseline to 1 month
Description
This is a measure of the degree of staining on the cornea.
Time Frame
1 month
Title
Change in Conjunctival staining score from baseline to 1 month
Description
This is a measure of the degree of staining on the conjunctiva
Time Frame
1 month
Title
Device-related adverse events
Description
Any untoward adverse event that is attributed to the study device
Time Frame
1 month
Title
Change in best spectacle-corrected visual acuity from baseline to 1 month
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Ripley
Phone
6616458546
Email
anne@sightsciences.com
Facility Information:
Facility Name
Eye Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvette Abbascia
Phone
949-650-1863
Email
yvette.abbascia@drwirta.com
Facility Name
Kentucky Eye Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Tincher
Email
justin.tincher@kyeye.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the TearCare System in Dry Eye Disease

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