Trial Outcomes & Findings for A Pilot Study of the TearCare System in Adults With Dry Eye Disease (NCT NCT03006978)
NCT ID: NCT03006978
Last Updated: 2025-10-15
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. An increase in TBUT represents an improvement.
COMPLETED
NA
24 participants
4 weeks
2025-10-15
Participant Flow
Participant milestones
| Measure |
TearCare
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
TearCare
|
Warm Compress
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Warm Compress
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of the TearCare System in Adults With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
TearCare
n=12 Participants
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
TearCare
|
Warm Compress
n=12 Participants
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Warm Compress
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe 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. An increase in TBUT represents an improvement.
Outcome measures
| Measure |
TearCare
n=12 Participants
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
TearCare
|
Warm Compress
n=12 Participants
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Warm Compress
|
|---|---|---|
|
Mean Change in Tear Breakup Time From Baseline to Month 1
|
11.7 seconds
Standard Deviation 2.6
|
-0.3 seconds
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 1 monthUsing a Korb Meibomian Gland Evaluator (TearScience), the meibomian gland assessment was conducted by evaluating the consistency of the secretions that were observed upon expression of meibomian glands in the nasal, central, and temporal regions of the lower eyelids. The central, consecutive 5 glands in each region were evaluated. The instrument was held at the eyelid margin for 10-15 seconds, and the secretions were graded on a 0-3 scale for each gland (0=no expression; 1=toothpaste; 2=cloudy; and 3=clear), with a 0-45 score range for each eye. The score for each eye of a subject was averaged. The change from baseline in the Meibomian Gland Score is the difference between the mean baseline value and the mean value at Month 1. A higher score represents an improvement.
Outcome measures
| Measure |
TearCare
n=12 Participants
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
TearCare
|
Warm Compress
n=12 Participants
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Warm Compress
|
|---|---|---|
|
Mean Change in Meibomian Gland Score From Baseline to Month 1
|
34.7 units on a scale
Standard Deviation 3.0
|
-0.8 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 1 MonthThe Standard Patient Evaluation for Eye Dryness (SPEED) questionnaire is a well-validated instrument and widely used assessment tool for dry eye indications. The SPEED questionnaire was used to evaluate 4 symptoms (1-dryness, grittiness, or scratchiness, 2-soreness or irritation, 3-burning or watering, 3-eye fatigue) of study subjects. The maximum score is 28 (worst) and the minimum possible is 0 (best). The SPEED survey measures the severity (0-4 scale - each symptom) and frequency (0-3 scale - each symptom) of these DED symptoms. The SPEED score was calculated by adding the total of the frequency and severity scores; a score of greater than or equal to 6 may be an indicator of DED. The reported value is the mean of the change for all subjects. A negative result indicates improvement.
Outcome measures
| Measure |
TearCare
n=12 Participants
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
TearCare
|
Warm Compress
n=12 Participants
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Warm Compress
|
|---|---|---|
|
Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score From Baseline
|
-7.9 units on a scale
Standard Deviation 4.3
|
-1.8 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 1 MonthThe 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
| Measure |
TearCare
n=12 Participants
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
TearCare
|
Warm Compress
n=12 Participants
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Warm Compress
|
|---|---|---|
|
Mean Change in OSDI Score From Baseline to Month 1
|
-25.3 units on a scale
Standard Deviation 17.9
|
-8.4 units on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: 1 MonthThe SANDE instrument is a simple 2-item questionnaire, that focuses on the frequency and the severity of dry eye symptoms with each measured along a visual analog scale. SANDE, because of its simplicity, is often used in routine clinical practice. For the core questions, the frequency and severity scores are multiplied together, and the square root is taken to produce an overall SANDE score from 0 (best possible) to 100 (worst possible). The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.
Outcome measures
| Measure |
TearCare
n=12 Participants
Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands.
TearCare
|
Warm Compress
n=12 Participants
Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Warm Compress
|
|---|---|---|
|
Mean Change in SANDE ( Symptom Assessment in Dry Eye) Questionnaire Score From Baseline to Month 1
|
-24.6 units on a scale
Standard Deviation 30.9
|
2.8 units on a scale
Standard Deviation 14.2
|
Adverse Events
TearCare
Warm Compress
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place