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Pilot Study of TearCare System - Long-Term Extension

Primary Purpose

Dry Eye Syndromes

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 Syndromes

Eligibility Criteria

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

Inclusion Criteria:

  • Previously enrolled in the TearCare arm of the TearCare Pilot Study
  • Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
  • TBUT of <10 seconds in at least one eye
  • Willing to comply with the study, procedures, and follow-up
  • Willing and able to provide consent

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TearCare

Arm Description

Subjects will receive one TearCare treatment at the baseline visit

Outcomes

Primary Outcome Measures

Tear Break-Up Time
Tear Break-Up Time measures the time (in seconds) to the first observation of breakup of the tear film.

Secondary Outcome Measures

Meibomian Gland Secretion Score
This is a measure of the quality of secretions from the meibomian glands. Each gland is score from 0-3; 15 glands of each lower eyelid are scored. Range of the score is 0-45.
SPEED II Questionnaire
The Standard Patient Evaluation of Dry Eye (SPEED) measures the severity and frequency of dry eye symptoms.
OSDI Questionnaire
The Ocular Surface Disease Index (OSDI) questionnaire assesses the ocular symptoms, impact on patient vision-related functioning, and environmental factors triggering the symptoms.
Corneal staining
This measures the degree of staining on the surface of the cornea using the NEI scale.
Conjunctival staining
This measures the degree of staining on the surface of the conjunctival using the NEI scale.
Adverse Events
All device-related and ocular adverse events will be collected.

Full Information

First Posted
January 11, 2019
Last Updated
January 11, 2019
Sponsor
Sight Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03804502
Brief Title
Pilot Study of TearCare System - Long-Term Extension
Official Title
Pilot Study of TearCare System - Long-Term Extension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (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
The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TearCare
Arm Type
Experimental
Arm Description
Subjects will receive one TearCare treatment at the baseline visit
Intervention Type
Device
Intervention Name(s)
TearCare
Intervention Description
The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
Primary Outcome Measure Information:
Title
Tear Break-Up Time
Description
Tear Break-Up Time measures the time (in seconds) to the first observation of breakup of the tear film.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Meibomian Gland Secretion Score
Description
This is a measure of the quality of secretions from the meibomian glands. Each gland is score from 0-3; 15 glands of each lower eyelid are scored. Range of the score is 0-45.
Time Frame
1 month
Title
SPEED II Questionnaire
Description
The Standard Patient Evaluation of Dry Eye (SPEED) measures the severity and frequency of dry eye symptoms.
Time Frame
1 month
Title
OSDI Questionnaire
Description
The Ocular Surface Disease Index (OSDI) questionnaire assesses the ocular symptoms, impact on patient vision-related functioning, and environmental factors triggering the symptoms.
Time Frame
1 month
Title
Corneal staining
Description
This measures the degree of staining on the surface of the cornea using the NEI scale.
Time Frame
1 month
Title
Conjunctival staining
Description
This measures the degree of staining on the surface of the conjunctival using the NEI scale.
Time Frame
1 month
Title
Adverse Events
Description
All device-related and ocular adverse events will be collected.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously enrolled in the TearCare arm of the TearCare Pilot Study Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6 TBUT of <10 seconds in at least one eye Willing to comply with the study, procedures, and follow-up Willing and able to provide consent 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
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 TearCare System - Long-Term Extension

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