Study of the TearCare System in Dry Eye Disease

Not Applicable

• Conditions: Dry Eye
• Interventions: Device: TearCare

• Registration Number: NCT03588624
• Lead Sponsor: Sight Sciences, Inc.

Brief Summary

This study is being conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.

NOTE: All sites have been selected for this study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-03
• Study Start: 2018-07-12
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosed with dry eye disease
• Signs and symptoms of dry eye disease
• Best corrected visual acuity 20/100 or better
• Willing and able to comply with study procedures
• Willing and able to provide consent

Exclusion Criteria

• Active ocular infection or inflammation
• History of eyelid, conjunctiva or corneal surgery within the past year.
• Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
• Contact lens wearer
• Significant ocular surface or eyelid abnormalities, recent ocular trauma
• Certain corneal surface abnormalities
• Use of medications for treatment of dry eye or medications that cause dry eye
• Systemic disease that results in dry eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TearCare	TearCare	All subjects in the study will undergo the TearCare procedure one time at the baseline visit. They will then be followed out to one month.

Primary Outcome Measures

Name	Time	Method
Change in Tear Break-up time from baseline to 1 month	1 month	Tear Break-up Time is defined as the number of seconds between a blink and the appearance of a first dry spot or negative staining in the tear film.

Secondary Outcome Measures

Name	Time	Method
Change in Ocular Surface Disease Index (OSDI) score from baseline to 1 month	1 month	The OSDI is a questionnaire that assesses the symptoms of dry eye disease
Change in Meibomian gland secretion score from baseline to 1 month	1 month	The is a measure of the quality of the secretions from the meibomian glands
Change in Cornea staining score from baseline to 1 month	1 month	This is a measure of the degree of staining on the cornea.
Change in Conjunctival staining score from baseline to 1 month	1 month	This is a measure of the degree of staining on the conjunctiva
Change in best spectacle-corrected visual acuity from baseline to 1 month	1 month
Device-related adverse events	1 month	Any untoward adverse event that is attributed to the study device

Trial Locations

Locations (2)

Eye Research Institute; 🇺🇸 Newport Beach, California, United States

Kentucky Eye Institute; 🇺🇸 Lexington, Kentucky, United States