Trial Outcomes & Findings for Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease (NCT NCT03502447)

Last Updated: 2025-09-29

Results Overview

The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement.

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

1 month

Results posted on

2025-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	TearCare TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands. 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 & Lid Massage Subjects will perform warm compress and lid massage at home daily. 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.
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TearCare n=7 Participants TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands. 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 & Lid Massage n=7 Participants Subjects will perform warm compress and lid massage at home daily. 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.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	69 years STANDARD_DEVIATION 10.1 • n=5 Participants	55.9 years STANDARD_DEVIATION 20.9 • n=7 Participants	62.45 years STANDARD_DEVIATION 18.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Tear Break Up Time	4.9 seconds STANDARD_DEVIATION 0.8 • n=5 Participants	4.7 seconds STANDARD_DEVIATION 0.7 • n=7 Participants	4.8 seconds STANDARD_DEVIATION 0.8 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	TearCare n=7 Participants TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands. 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 & Lid Massage n=7 Participants Subjects will perform warm compress and lid massage at home daily. 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.
Mean Change in Tear Break-Up Time From Baseline to Month 1	1.4 seconds Standard Deviation 2.3	2.5 seconds Standard Deviation 2.8

SECONDARY outcome

Timeframe: 1 month

The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 1 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects.

Outcome measures

Outcome measures
Measure	TearCare n=7 Participants TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands. 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 & Lid Massage n=7 Participants Subjects will perform warm compress and lid massage at home daily. 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.
Mean Change in OSDI Score From Baseline to Month 1	-13.7 units on a scale Standard Deviation 12.5	-10.0 units on a scale Standard Deviation 7.7

Adverse Events

TearCare

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warm Compress & Lid Massage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP Medical & Clinical Affairs

Sight Sciences, Inc.

Phone: 877-266-1144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place