Trial Outcomes & Findings for Pilot Study of TearCare System - Long-Term Extension (NCT NCT03804502)
NCT ID: NCT03804502
Last Updated: 2025-10-28
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 resulting in a single TBUT value for each subject (n=12).
COMPLETED
NA
12 participants
1 month
2025-10-28
Participant Flow
Participant milestones
| Measure |
TearCare
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of TearCare System - Long-Term Extension
Baseline characteristics by cohort
| Measure |
TearCare
n=24 eyes
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Tear Break Up Time
|
5.0 seconds
STANDARD_DEVIATION 1.1 • n=32 eyes
|
PRIMARY outcome
Timeframe: 1 monthPopulation: All subjects that had been randomized to TearCare in the initial pilot study (NCT03006978) and consented to participate in the extension study.
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 resulting in a single TBUT value for each subject (n=12).
Outcome measures
| Measure |
TearCare
n=24 eyes
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Mean Change in Tear Break-Up Time From Extension Study Baseline to Month 1
|
12.4 seconds
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All subjects that had been randomized to TearCare in the initial pilot study (NCT03006978) and consented to participate in the extension study.
Using 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 (worst)-45 (best) 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 positive value for change is an improvement
Outcome measures
| Measure |
TearCare
n=24 eyes
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Mean Change in Meibomian Gland Score From Extension Study Baseline to Month 1
|
19.5 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All subjects that had been randomized to TearCare in the initial pilot study (NCT03006978) and consented to participate in the extension study.
The Standard Patient Evaluation for Eye Dryness II (SPEED II) questionnaire is a well-validated instrument and widely used assessment tool for dry eye indications. The SPEED II questionnaire was used to evaluate the symptoms of study subjects. The SPEED II survey measures the severity (0-4 scale) and frequency (0-3 scale) of 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 (range 0 \[best\] to 7 \[worst\]). 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 one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Mean Change in SPEED II Questionnaire Result From Extension Study Baseline to Month 1
|
-2.9 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All subjects that had been randomized to TearCare in the initial pilot study (NCT03006978) and consented to participate in the extension study.
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
| Measure |
TearCare
n=12 Participants
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Mean Change in OSDI Questionnaire Result From Extension Study Baseline to Month 1.
|
-11.2 units on a scale
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All subjects that had been randomized to TearCare in the initial pilot study (NCT03006978) and consented to participate in the extension study.
Corneal (fluorescein) staining scores was recorded to assess the integrity of the ocular surface. The severity of staining was assessed and quantified using the National Eye Institute/Industry Grading System scoring 5 regions of the cornea using a scale from 0 to 3 (normal-severe) for each region. The scores for the regions of the cornea were added to obtain a total score that ranged from 0 (best) to 15 (worst). The score for each eye of a subject was averaged. 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=24 eyes
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Mean Change in Corneal Staining From Extension Study Baseline to Month 1
|
-0.17 units on a scale
Standard Deviation .33
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All subjects that had been randomized to TearCare in the initial pilot study (NCT03006978) and consented to participate in the extension study.
Conjunctival (lissamine green) staining scores was recorded to assess the integrity of the ocular surface. The severity of staining was assessed and quantified using the National Eye Institute/Industry Grading System scoring 6 regions of the conjunctiva using a scale from 0 to 3 (normal-severe) for each region. The scores for the regions of the conjunctiva were added to obtain a total score that ranged from 0 (best) to 18 (worst). The score for each eye of a subject was averaged. 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=24 eyes
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Mean Change in Conjunctival Staining From Extension Study Baseline to Month 1
|
-0.54 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All subjects that had been randomized to TearCare in the initial pilot study (NCT03006978) and consented to participate in the extension study.
The SANDE (Symptom Assessment iN Dry Eye) 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 one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
Mean Change in SANDE Result From Extension Study Baseline to Month 1
|
-13.2 score on a scale
Standard Deviation 15.6
|
Adverse Events
TearCare
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TearCare
n=8 participants at risk
Subjects will receive one TearCare treatment at the baseline visit
TearCare: The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
|
|---|---|
|
General disorders
mild allergic conjunctivitis
|
12.5%
1/8 • Number of events 1 • 1 month
|
Additional Information
VP, Medical and Clinical Affairs
Sight Sciences, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place