TearCare System to Treat Dry Eye Disease

Not Applicable

Recruiting

• Conditions: Meibomian Gland Dysfunction; Dry Eye
• Interventions: Device: LipiFlow; Device: TearCare

• Registration Number: NCT03857919
• Lead Sponsor: Sight Sciences, Inc.

Brief Summary

In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Study Start: 2019-03-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• At least 22
• Subject has dry eye symptoms and uses artificial tears/lubricants regularly
• Subject has moderate to severe symptoms based on a dry eye questionnaire
• Subject has an abnormal tear break-up time
• Subject's eyelid glands secrete a low amount of meibum
• Best corrected visual acuity 20/100 or better
• Willing and able to comply with protocol
• Willing and able to provide consent
• English-speaking

Key

Exclusion Criteria

• Use of medications that treat dry eye disease or that are known to cause ocular dryness.
• Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs
• Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing.
• History of eyelid, conjunctival or corneal surgery within the past year.
• Contact lens use within past 2 weeks
• Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LipiFlow	LipiFlow	Subjects will have heat and pressure applied to the eyelids for 12 minutes.
TearCare	TearCare	Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands.

Primary Outcome Measures

Name	Time	Method
Meibomian Gland Secretion Score	1 month	The Meibomian Gland Secretion score is the measure of the quality of the secretions in the meibomian glands. Secretions are scored on a scale from 0-3, with 0 indicating no secretion and 3 indicating clear secretions. Fifteen glands are scored in each lower eyelid. Total score ranges from 0-45.
Tear Break-Up Time	1 month	Tear Break-Up Time is the time measured to the first observation of a break in the tear film

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI)	1 month	The OSDI is a questionnaire that measures the severity of symptoms of dry eye disease. Total score can range from 0-100. A score of 0-12 is normal, 13-22 is mild, 23-32 is moderate, and 33-100 is severe dry eye.
Conjunctival staining score	1 month	This scores the amount of staining observed on the surface of the conjunctiva using the NEI scale. Six regions of the conjunctiva are scored on a scale from 0-3, with 0 being no staining and 3 being the most staining. The total score can range from 0-18.
SANDE	1 month	Symptom Assessment iN Dry Eye (SANDE) questionnaire is a visual analog scale the measures the severity and frequency of dry eye symptoms. The scale ranges from 0 to 100 with 0 being the least and 100 being the worst.
Corneal staining score	1 month	This scores the amount of staining observed on the surface of the cornea using the NEI Scale. Five regions of the cornea are scored on a scale from 0-3, with 0 being no staining and 3 being the most staining. The total score can range from 0-15.
Meibomian glands yielding clear secretions	1 month	This is a count of the number of glands scored as having clear secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best.
Meibomian glands yielding clear or cloudy secretions	1 month	This is a count of the glands scored as having clear or cloudy secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best..
Eye Dryness Score	1 month	Eye Dryness Score is a visual analog scale the measures the level of discomfort related to eye dryness. The scale ranges from 0 to 100 with 0 being the least and 100 being the worst.

Trial Locations

Locations (1)

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States