Trial Outcomes & Findings for Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA) (NCT NCT04795752)

Last Updated: 2025-11-24

Results Overview

Change in Ocular Surface Disease Index (OSDI) score from baseline to 6-months. The 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 6 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

345 participants

Primary outcome timeframe

6 months

Results posted on

2025-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	TearCare Group (Study Device) TearCare System TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months. Beginning at 9 Months, subjects will receive an additional TearCare procedure when TBUT drops lower than Baseline or within 2 seconds of baseline AND/OR if OSDI worsens by at least 1 category. These subjects will continue follow-up through 24 months.	Restasis Group (Control) Restasis® (0.05% Cyclosporine ophthalmic emulsion Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At Month 6, subjects will be crossed over to the TearCare group and will receive one (1) TearCare procedure. Following this single TearCare procedure, these subjects will be followed for an additional 6 months (12 months total).
Primary Endpoint Phase STARTED	172	173
Primary Endpoint Phase COMPLETED	155	163
Primary Endpoint Phase NOT COMPLETED	17	10
X-over-Restasis arm; Durability-TC arm STARTED	155	163
X-over-Restasis arm; Durability-TC arm COMPLETED	142	161
X-over-Restasis arm; Durability-TC arm NOT COMPLETED	13	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TearCare Group (Study Device) TearCare System TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months. Beginning at 9 Months, subjects will receive an additional TearCare procedure when TBUT drops lower than Baseline or within 2 seconds of baseline AND/OR if OSDI worsens by at least 1 category. These subjects will continue follow-up through 24 months.	Restasis Group (Control) Restasis® (0.05% Cyclosporine ophthalmic emulsion Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At Month 6, subjects will be crossed over to the TearCare group and will receive one (1) TearCare procedure. Following this single TearCare procedure, these subjects will be followed for an additional 6 months (12 months total).
Primary Endpoint Phase Withdrawal by Subject	7	7
Primary Endpoint Phase Lost to Follow-up	3	2
Primary Endpoint Phase Physician Decision	2	0
Primary Endpoint Phase Other	4	1
Primary Endpoint Phase Protocol Violation	1	0
X-over-Restasis arm; Durability-TC arm Lost to Follow-up	7	0
X-over-Restasis arm; Durability-TC arm Withdrawal by Subject	1	1
X-over-Restasis arm; Durability-TC arm Physician Decision	1	0
X-over-Restasis arm; Durability-TC arm Death	1	0
X-over-Restasis arm; Durability-TC arm Other	3	1

Baseline Characteristics

Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TearCare Group (Study Device) n=344 eyes TearCare System TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months.	Restasis Group (Control) n=346 eyes Restasis® (0.05% Cyclosporine ophthalmic emulsion Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit.	Total n=690 eyes Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=45 Participants	114 Participants n=12929 Participants	227 Participants n=6349 Participants
Age, Categorical >=65 years	59 Participants n=45 Participants	59 Participants n=12929 Participants	118 Participants n=6349 Participants
Age, Continuous	55.5 years STANDARD_DEVIATION 14.8 • n=45 Participants	56.8 years STANDARD_DEVIATION 13.1 • n=12929 Participants	56.2 years STANDARD_DEVIATION 14.0 • n=6349 Participants
Sex: Female, Male Female	120 Participants n=45 Participants	128 Participants n=12929 Participants	248 Participants n=6349 Participants
Sex: Female, Male Male	52 Participants n=45 Participants	45 Participants n=12929 Participants	97 Participants n=6349 Participants
Race/Ethnicity, Customized Subject Demographics · Asian	9 Participants n=45 Participants	7 Participants n=12929 Participants	16 Participants n=6349 Participants
Race/Ethnicity, Customized Subject Demographics · Black/African American	6 Participants n=45 Participants	12 Participants n=12929 Participants	18 Participants n=6349 Participants
Race/Ethnicity, Customized Subject Demographics · White/Caucasian	155 Participants n=45 Participants	151 Participants n=12929 Participants	306 Participants n=6349 Participants
Race/Ethnicity, Customized Subject Demographics · Other/mixed	2 Participants n=45 Participants	3 Participants n=12929 Participants	5 Participants n=6349 Participants
Region of Enrollment United States	172 participants n=45 Participants	173 participants n=12929 Participants	345 participants n=6349 Participants
Tear Break Up Time	4.39 seconds STANDARD_DEVIATION 1.26 • n=2 eyes	4.37 seconds STANDARD_DEVIATION 1.18 • n=56 eyes	4.38 seconds STANDARD_DEVIATION 1.21 • n=112 eyes
OSDI	50.0 units on a scale STANDARD_DEVIATION 14.9 • n=45 Participants	50.0 units on a scale STANDARD_DEVIATION 14.9 • n=12929 Participants	50.0 units on a scale STANDARD_DEVIATION 14.9 • n=6349 Participants

PRIMARY outcome

Timeframe: 6 months

Change in Tear Break-Up Time (TBUT) from baseline to month 6

Outcome measures

Outcome measures
Measure	TearCare Group (Study Device) n=344 eyes TearCare System TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months. Beginning at 9 Months, subjects will receive an additional TearCare procedure when TBUT drops lower than Baseline or within 2 seconds of baseline AND/OR if OSDI worsens by at least 1 category.	Restasis Group (Control) n=346 eyes Restasis® (0.05% Cyclosporine ophthalmic emulsion Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At Month 6, subjects will be crossed over to the TearCare group and will receive one (1) TearCare procedure.
Tear Break-Up Time	2.71 seconds Standard Deviation 3.35	1.22 seconds Standard Deviation 2.46

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	TearCare Group (Study Device) n=172 Participants TearCare System TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months. Beginning at 9 Months, subjects will receive an additional TearCare procedure when TBUT drops lower than Baseline or within 2 seconds of baseline AND/OR if OSDI worsens by at least 1 category.	Restasis Group (Control) n=173 Participants Restasis® (0.05% Cyclosporine ophthalmic emulsion Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At Month 6, subjects will be crossed over to the TearCare group and will receive one (1) TearCare procedure.
OSDI Score	-18.25 score on a scale Standard Error 17.98	-15.53 score on a scale Standard Error 19.86

Adverse Events

TearCare Group (Study Device) (Baseline to 24 months)

Serious events: 2 serious events

Other events: 23 other events

Deaths: 1 deaths

Restasis Group (Control) (Baseline to Month 6)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Restasis Subjects crossed over to TearCare (Month 6- Month 12

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TearCare Group (Study Device) (Baseline to 24 months) n=172 participants at risk TearCare System TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months; this arm followed through 24 months.	Restasis Group (Control) (Baseline to Month 6) n=173 participants at risk Restasis® (0.05% Cyclosporine ophthalmic emulsion Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit.	Restasis Subjects crossed over to TearCare (Month 6- Month 12 n=163 participants at risk Subjects randomized to Restasis stopped Restasis at Month 6 and received a single TearCare treatment at Month 6. Subjects were followed through Month 12.
General disorders Cholelithiasis	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Reproductive system and breast disorders Pulmonary Edema	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Hepatobiliary disorders Gall bladder tumor	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.

Other adverse events

Additional Information

VP, Medical and Clinical Affairs

Sight Sciences, Inc

Phone: 1-877-266-1144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After Sponsor's publication of trial results, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to the obligations of the CTA, and prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure at least 60 days prior to submission for publication or disclosure. Sponsor may request changes or other measures to ensure the information is fairly stated.
Publication restrictions are in place

Restriction type: OTHER

Measure	TearCare Group (Study Device) (Baseline to 24 months) n=172 participants at risk TearCare System TearCare System: TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months; this arm followed through 24 months.	Restasis Group (Control) (Baseline to Month 6) n=173 participants at risk Restasis® (0.05% Cyclosporine ophthalmic emulsion Restasis: Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit.	Restasis Subjects crossed over to TearCare (Month 6- Month 12 n=163 participants at risk Subjects randomized to Restasis stopped Restasis at Month 6 and received a single TearCare treatment at Month 6. Subjects were followed through Month 12.
Eye disorders Eyelid irritation	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.61% 1/163 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders chalazion	2.3% 4/172 • Number of events 4 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.58% 1/173 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Foreign body sensation	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	1.2% 2/173 • Number of events 2 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders New Onset Vitreous Floaters and Photopsia	0.00% 0/172 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	1.7% 3/173 • Number of events 3 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.61% 1/163 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Posterior vitreous detachment	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.58% 1/173 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Preseptal Cellulitis	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Subconjunctival Hemorrhage	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Vitreomacular Traction	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Worsening of Dry Eye	1.2% 2/172 • Number of events 2 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Worsening of Preexisting condition	0.00% 0/172 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.61% 1/163 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Infection eyelid or ocular surface	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Loss of BCVA of ≥ 10 letters	3.5% 6/172 • Number of events 7 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	1.2% 2/173 • Number of events 4 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	2.5% 4/163 • Number of events 4 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Swelling of the eyelid(s)	1.2% 2/172 • Number of events 2 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Allergic Conjunctivitis	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.58% 1/173 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Blepharitis	0.00% 0/172 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.58% 1/173 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Blurred Vision	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.58% 1/173 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Conjunctival hyperemia	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.58% 1/173 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Corneal Erosion	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Discomfort post instillation of drops	0.00% 0/172 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	1.2% 2/173 • Number of events 2 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders conjunctival cyst	0.00% 0/172 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.61% 1/163 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders Filamentary keratitis	0.00% 0/172 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.61% 1/163 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders blepharochalasis	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders macular degeneration	1.2% 2/172 • Number of events 2 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders canaliculitis	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders corneal infiltrate	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders epiretinal membrane	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.
Eye disorders macular cystic changes	0.58% 1/172 • Number of events 1 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/173 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.	0.00% 0/163 • 24 months; TearCare subjects were followed for 24 months while Restasis subjects were followed for 12 months. AEs were monitored and collected for the Safety population - All subjects exposed to treatment.