Pilot Study of the TearCare System

Dry Eye Clinical Trial

Official title:

Pilot Study of the TearCare System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03006978
• Other study ID #: 05429
• Status: Active, not recruiting
• Phase: N/A
• First received: December 27, 2016
• Last updated: August 7, 2017
• Start date: December 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2017
• Source: Sight Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: February 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Dry Eye

Intervention

Device:
• TearCare

• Warm Compress

Locations

Country	Name	City	State
United States	Central Eye Care, Ltd.	Arlington Heights	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Breakup Time		4 weeks
Secondary	Meibomian Gland Assessment		Day 1, Week 2, Week 4, 3 Month, 6 Month
Secondary	Dry Eye Symptoms and Quality of Life		Week 2, Week 4, 3 Month, 6 Month
Secondary	Change in Medication Use		Day 1, Week 2, Week 4, 3 Month, 6 Month
Secondary	Adverse Events		Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month