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Pilot Study of the TearCare System

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TearCare
Warm Compress
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

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

Inclusion Criteria:

  • Dry eye symptoms within 30 months of the screening exam with a SPEED score >=6
  • Schirmer 1 value of <010 mm in at least one eye or a Tear Breakup time <10 seconds in at least one eye

Exclusion Criteria:

  • 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.)

Sites / Locations

  • Central Eye Care, Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TearCare

Warm Compress

Arm Description

Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.

Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.

Outcomes

Primary Outcome Measures

Tear Breakup Time

Secondary Outcome Measures

Meibomian Gland Assessment
Dry Eye Symptoms and Quality of Life
Change in Medication Use
Adverse Events

Full Information

First Posted
December 27, 2016
Last Updated
August 7, 2017
Sponsor
Sight Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03006978
Brief Title
Pilot Study of the TearCare System
Official Title
Pilot Study of the TearCare System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of the TearCare™ System compared to standardized warm compress therapy for the application of controlled, localized heat therapy in adult patients with dry eye syndrome.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TearCare
Arm Type
Experimental
Arm Description
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
Arm Title
Warm Compress
Arm Type
Active Comparator
Arm Description
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Intervention Type
Device
Intervention Name(s)
TearCare
Intervention Type
Device
Intervention Name(s)
Warm Compress
Primary Outcome Measure Information:
Title
Tear Breakup Time
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Meibomian Gland Assessment
Time Frame
Day 1, Week 2, Week 4, 3 Month, 6 Month
Title
Dry Eye Symptoms and Quality of Life
Time Frame
Week 2, Week 4, 3 Month, 6 Month
Title
Change in Medication Use
Time Frame
Day 1, Week 2, Week 4, 3 Month, 6 Month
Title
Adverse Events
Time Frame
Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dry eye symptoms within 30 months of the screening exam with a SPEED score >=6 Schirmer 1 value of <010 mm in at least one eye or a Tear Breakup time <10 seconds in at least one eye Exclusion Criteria: 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.)
Facility Information:
Facility Name
Central Eye Care, Ltd.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of the TearCare System

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