Trial Outcomes & Findings for Study of the TearCare System in Dry Eye Disease (NCT NCT03588624)

NCT ID: NCT03588624

Last Updated: 2025-09-11

Results Overview

TBUT is an indicator of tear film instability and measures the length of time it takes for the tear film to break down. An increase in TBUT represents an improvement.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2025-09-11

Participant Flow

Participant milestones

Measure	TearCare (Single Procedure) All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the TearCare System in Dry Eye Disease

Baseline characteristics by cohort

Measure	TearCare (Single Procedure) n=29 Participants All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Age, Customized	60.6 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized White	26 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants
Single TearCare® procedure to treat adult patients with dry eye disease	29 Participants n=5 Participants
Tear Break Up Time	3.7 seconds STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

TBUT is an indicator of tear film instability and measures the length of time it takes for the tear film to break down. An increase in TBUT represents an improvement.

Outcome measures

Measure	TearCare (Single Procedure) n=29 Participants All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Mean Change in Tear Break-Up Time (TBUT) at 1-month From Baseline	3.1 seconds Standard Deviation 2.2

SECONDARY outcome

Timeframe: 1 month

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.

OSDI Scale Dry Eye Grade 12 or less - Normal 13-22 - Mild 23-32 - Moderate 33 or greater - Severe. Scores may range from 0 (best possible), to 100 (worst possible).

Mean change from baseline at Month 1 is the difference between the mean score at Month 1 and at baseline. A negative score represents improvement.

Outcome measures

Measure	TearCare (Single Procedure) n=29 Participants All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Month 1	25.8 scores on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: 1 month

The Meibomian Gland Secretion Scoring is an assessment of the quality of the secretions produced by the meibomian glands in the lower eyelids. 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 (Single Procedure) n=29 Participants All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Total Meibomian Gland Secretion Score at 1 Month	14.4 score on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: 1 month

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 (Single Procedure) n=29 Participants All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Corneal Staining Score at1 Month	4.1 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 1 Month

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 (Single Procedure) n=29 Participants All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Conjunctival Staining Score at 1 Month	4.7 score on a scale Standard Deviation 3.0

Adverse Events

TearCare (Single Procedure)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TearCare (Single Procedure) n=29 participants at risk All subjects in the study were successfully treated with the TearCare device and manual expression of their eyelids, one time at the baseline visit.
Eye disorders Worsening of two or more lines on the Snellen visual acuity	6.9% 2/29 • Number of events 4 • 1 Month

Additional Information

VP Medical and Clinical Affairs

Sight Sciences

Phone: (877) 266-1144

Email: info@sightsciences.com

Results disclosure agreements

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