Study of the TearCare System in Dry Eye Disease

Dry Eye Clinical Trial

Official title:

Study of the TearCare System in Dry Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588624
• Other study ID #: 06001
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: September 2018

Study information

• Verified date: August 2018
• Source: Sight Sciences, Inc.
• Contact: Anne Ripley
• Phone: 6616458546
• Email: anne[@]sightsciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• 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
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• TearCare
The TearCare procedure includes the delivery of thermal energy to the external surface of the eyelids for 15 minutes, immediately followed by manual expression of each eyelid.

Locations

Country	Name	City	State
United States	Kentucky Eye Institute	Lexington	Kentucky
United States	Eye Research Institute	Newport Beach	California

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