Trial Outcomes & Findings for TearCare System to Treat Dry Eye Disease (NCT NCT03857919)

NCT ID: NCT03857919

Last Updated: 2025-10-01

Results Overview

Tear Break-Up Time is the time measured to the first observation of a break in the tear film

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 235 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2025-10-01

Participant Flow

Participant milestones

Measure	TearCare Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Overall Study STARTED	115	120
Overall Study COMPLETED	115	120
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TearCare System to Treat Dry Eye Disease

Baseline characteristics by cohort

Measure	TearCare n=115 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=120 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.	Total n=235 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 14.0 • n=5 Participants	55 years STANDARD_DEVIATION 14.5 • n=7 Participants	55.9 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	83 Participants n=7 Participants	169 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	37 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants	101 Participants n=7 Participants	195 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 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	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	109 Participants n=7 Participants	213 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Tear Break Up Time	4.5 seconds STANDARD_DEVIATION 1.2 • n=5 Participants	4.5 seconds STANDARD_DEVIATION 1.2 • n=7 Participants	4.5 seconds STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

Tear Break-Up Time is the time measured to the first observation of a break in the tear film

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Tear Break-Up Time (TBUT) From Baseline	3.02 Seconds Standard Deviation 4.41	2.58 Seconds Standard Deviation 3.28

PRIMARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

The Meibomian Gland Secretion Score grades the consistency of secretions from the meibomian glands. Fifteen meibomian glands in each of the lower eyelids were gently pressed and the secretions were scored on the scale below. Sum of the grade (0 - 3) for each of the 15 glands. Range for this score is 0-45. A higher number indicates more normal meibomian gland activity.

Score Description of Secretion:

0 - Nothing

1. - Toothpaste

2. - Cloudy

3. - Clear

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Meibomian Gland Secretion Score From Baseline	11.20 score on a scale Standard Deviation 11.13	11.09 score on a scale Standard Deviation 10.41

SECONDARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

The Ocular Surface Disease Index (OSDI) questionnaire is a validated questionnaire that consists of 12 questions to assess ocular symptoms, their impact on patient vision-related functioning, and environmental factors triggering the symptoms. Scale range is zero (best possible score) to 100 (worst possible score). Mean change is the average of the difference between Month 1 and baseline for each subject. A negative result represents improvement.

OSDI Scale Dry Eye Grade 12 or less - Normal 13-22 - Mild 23-32 - Moderate 33 or greater - Severe

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline	-27.88 score on a scale Standard Deviation 20.48	-23.40 score on a scale Standard Deviation 17.71

SECONDARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

The structural effect of dry eye disease (DED) on subjects' ocular surface and its severity was assessed using corneal and conjunctival staining. The degree of staining was quantified using the NEI/Industry Grading System which scores 5 regions of the cornea and 6 regions of the conjunctiva using a scale from 0 to 3. On this scale, 0 indicates no staining and 3 indicates severe staining. The score for the regions of the cornea were added to obtain a total score that ranged from 0-15 where 0 indicates no ocular surface damage or dry eye.

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Corneal Staining Score From Baseline	-0.25 score on a scale Standard Deviation 1.98	-0.57 score on a scale Standard Deviation 2.01

SECONDARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

The structural effect of dry eye disease (DED) on subjects' ocular surface and its severity was assessed using corneal and conjunctival staining. The degree of staining was quantified using the NEI/Industry Grading System which scores 5 regions of the cornea and 6 regions of the conjunctiva using a scale from 0 to 3. On this scale, 0 indicates no staining and 3 indicates severe staining. The score for the regions of the conjunctiva were added to obtain a total score that ranged from 0-18, where 0 indicates no ocular surface damage or dry eye.

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Conjunctival Staining Score From Baseline	-0.66 score on a scale Standard Deviation 2.26	-0.78 score on a scale Standard Deviation 3.18

SECONDARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

The 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=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Symptom Assessment in Dry Eye (SANDE) Scores From Baseline	-38.21 score on a scale Standard Deviation 31.05	-39.41 score on a scale Standard Deviation 25.97

SECONDARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

Severity of dry eye symptoms assessed on a 100 mm visual analog scale (VAS) ranging from 'Never/Very comfortable' to 'All the time/Very severe' and scored from 0 to 100: "0" = no discomfort/very comfortable, "100" = very severe.

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Eye Dryness Score (EDS) From Baseline	-35.43 score on a scale Standard Deviation 34.11	-34.87 score on a scale Standard Deviation 26.99

SECONDARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

This is a count of the number of glands scored as having clear secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best.

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Total Number of Meibomian Glands Yielding Clear Liquid From Baseline	1.82 Number of meibomian glands Standard Deviation 3.74	1.83 Number of meibomian glands Standard Deviation 3.54

SECONDARY outcome

Timeframe: 1 month

Population: Primary Analysis Population

This is a count of the number of glands scored as having any secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best.

Outcome measures

Measure	TearCare n=67 Participants Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=68 Participants Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Change in Total Number of Meibomian Glands Yielding Any Liquid From Baseline	4.31 Number of meibomian glands Standard Deviation 3.66	4.35 Number of meibomian glands Standard Deviation 3.42

Adverse Events

TearCare

Serious events: 0 serious events

Other events: 7 other events

Deaths: 7 deaths

LipiFlow

Serious events: 0 serious events

Other events: 8 other events

Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TearCare n=115 participants at risk Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. TearCare: The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.	LipiFlow n=120 participants at risk Subjects will have heat and pressure applied to the eyelids for 12 minutes. LipiFlow: The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
Eye disorders Chalazion	0.87% 1/115 • Number of events 1 • 1 Month	0.00% 0/120 • 1 Month
Eye disorders Superficial Punctate Keratitis (SPK)	0.87% 1/115 • Number of events 1 • 1 Month	0.00% 0/120 • 1 Month
Eye disorders Decrease in BCVA	1.7% 2/115 • Number of events 2 • 1 Month	0.83% 1/120 • Number of events 1 • 1 Month
Eye disorders Blepharitis	0.87% 1/115 • Number of events 1 • 1 Month	0.83% 1/120 • Number of events 1 • 1 Month
Eye disorders Conjunctival Injection	0.87% 1/115 • Number of events 1 • 1 Month	0.00% 0/120 • 1 Month
Eye disorders Iritis	0.87% 1/115 • Number of events 1 • 1 Month	0.00% 0/120 • 1 Month
Eye disorders Epiphora	0.00% 0/115 • 1 Month	0.83% 1/120 • Number of events 1 • 1 Month
Eye disorders Foreign Body Sensation	0.00% 0/115 • 1 Month	1.7% 2/120 • Number of events 2 • 1 Month
Eye disorders Ocular Pain	0.00% 0/115 • 1 Month	0.83% 1/120 • Number of events 1 • 1 Month
Eye disorders Corneal Abrasion	0.00% 0/115 • 1 Month	0.83% 1/120 • Number of events 1 • 1 Month
Eye disorders Dry Eye Disease	0.00% 0/115 • 1 Month	0.83% 1/120 • Number of events 1 • 1 Month

Additional Information

Tommie Rodriguez, Senior Clinical Research Manager

Sight Sciences

Phone: 18186873310

Email: trodriguez@sightsciences.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60