Pilot Study of the TearCare System

Not Applicable

• Conditions: Dry Eye
• Interventions: Device: Warm Compress; Device: TearCare

• Registration Number: NCT03006978
• Lead Sponsor: Sight Sciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2016-12-29
• Study First Posted: 2016-12-30
• Primary Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm Compress	Warm Compress	Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
TearCare	TearCare	Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.

Primary Outcome Measures

Name	Time	Method
Tear Breakup Time	4 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month
Meibomian Gland Assessment	Day 1, Week 2, Week 4, 3 Month, 6 Month
Dry Eye Symptoms and Quality of Life	Week 2, Week 4, 3 Month, 6 Month
Change in Medication Use	Day 1, Week 2, Week 4, 3 Month, 6 Month

Trial Locations

Locations (1)

Central Eye Care, Ltd.; 🇺🇸 Arlington Heights, Illinois, United States