Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03502447
• Other study ID #: 05474
• Status: Terminated
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: January 2, 2019

Study information

• Verified date: September 2019
• Source: Sight Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage 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 and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.

NOTE: All sites have been selected for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Signs and Symptoms

Intervention

Device:
• TearCare
TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands.
• Warm Compress and Lid Massage
Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage.

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Harvard Eye Associates	Laguna Hills	California
United States	Center for Excellence in Eye Care	Miami	Florida
United States	Eye Research Foundation	Newport Beach	California
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Vance Thompson Vision	Sioux Falls	South Dakota

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 Break-Up Time		1 month
Secondary	Ocular Surface Disease Index (OSDI)	This is a questionnaire that measures the severity of symptoms of dry eye disease.	1 month
Secondary	Meibomian Gland Score	The Meibomian Gland Secretion Scoring is an assessment of the quality of the secretions produced by the meibomian glands in the lower eyelids. Fifteen glands in each lower eyelid are scored. The Score is calculated by summing the grade (0 - 3) for each of the 15 glands. Range for this score is 0-45, with 45 being the best and 0 being the worst.	1 month
Secondary	Corneal and conjunctival staining graded using the NEI/Industry Grading System.	For corneal staining, the assessor scores 5 areas of the cornea (grade 0-3) and sums the grade for each area to obtain the total score. The score ranges from 0-15 with 0 being the best and 15 being the worst.; For conjunctival staining, the assessor scores 6 areas of the conjunctiva (grade 0-3) and sums the grade for each area to obtain the total score. The score ranges from 0-18 with 0 being the best and 18 being the worst.	1 month
Secondary	Symptom Assessment in Dry Eye (SANDE) and Eye Dryness Visual Analog Scale (VAS)	The SANDE is a simple dry eye instrument containing two items measuring the frequency and severity of symptoms, each is assessed on a 100 mm visual analog scale. The Eye Dryness (VAS) measures the level of discomfort associated with eye dryness on a 100mm VAS. The score for each question is calculated by measuring the distance from the left end of the line to the subject's response (range 0-100).; For these scales, a lower score is better than a higher score.	1 month
Secondary	Adverse Events		1 month