Study of the TearCare System in Dry Eye Disease

Not Applicable

• Conditions: Dry Eye

• 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

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