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Trial record 1 of 1 for:    TearCare
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Pilot Study of the TearCare System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sight Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT03006978
First received: December 27, 2016
Last updated: August 7, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Dry Eye Device: TearCare Device: Warm Compress

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the TearCare System

Further study details as provided by Sight Sciences, Inc.:

Primary Outcome Measures:
  • Tear Breakup Time [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Meibomian Gland Assessment [ Time Frame: Day 1, Week 2, Week 4, 3 Month, 6 Month ]
  • Dry Eye Symptoms and Quality of Life [ Time Frame: Week 2, Week 4, 3 Month, 6 Month ]
  • Change in Medication Use [ Time Frame: Day 1, Week 2, Week 4, 3 Month, 6 Month ]
  • Adverse Events [ Time Frame: Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month ]

Enrollment: 24
Study Start Date: December 2016
Estimated Study Completion Date: February 2018
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TearCare
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
Device: TearCare
Active Comparator: Warm Compress
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Device: Warm Compress

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03006978

Locations
United States, Illinois
Central Eye Care, Ltd.
Arlington Heights, Illinois, United States, 60005
Sponsors and Collaborators
Sight Sciences, Inc.
  More Information

Responsible Party: Sight Sciences, Inc.
ClinicalTrials.gov Identifier: NCT03006978     History of Changes
Other Study ID Numbers: 05429
Study First Received: December 27, 2016
Last Updated: August 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on August 22, 2017