Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease

This prospective, randomized, controlled, single-masked, multi-center treatment study will recruit 200 subjects with dry eye disease (OSDI Score of ≥23, TBUT of ≤7 seconds in both eyes, Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye and best corrected visual acuity of 20/100 or better in both eyes). Subject will be at least 22 years of age with reports of dry eye symptoms within the past 3 months, having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms and willingness to comply with the study procedures and follow-up for 12 months.

All subjects will complete an informed consent form indicating their voluntary participation in the study.

Study Measurements will be made at baseline (Day 0 - randomization to TearCare or Warm Compress/Lid Massage) and at Day 1, Week 1, and Months 1, 3, 6, 7, 9, 12.

• TearCare (Device): TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands.
• Warm Compress and Lid Massage (Device): Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage.

Primary outcomes

• Mean Change in Tear Break-Up Time From Baseline to Month 1 [1 month]: 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. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement.

Secondary outcomes

• Mean Change in OSDI Score From Baseline to Month 1 [1 month]: 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.

Sex: All, ages: 22 Years to any

Inclusion Criteria:

* Diagnosed with dry eye disease
* Signs and symptoms of dry eye disease
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with study procedures
* Willing and able to provide consent

Exclusion Criteria:

* Active ocular infection or inflammation
* History of eyelid, conjunctiva or corneal surgery within the past year.
* Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
* Contact lens wearer
* Significant ocular surface or eyelid abnormalities, recent ocular trauma
* Certain corneal surface abnormalities
* Use of medications for treatment of dry eye or medications that cause dry eye
* Systemic disease that results in dry eye

Participant flow

Outcome results

• Mean Change in Tear Break-Up Time From Baseline to Month 1 (Primary), Mean, seconds: TearCare 1.4 +/- 2.3; Warm Compress & Lid Massage 2.5 +/- 2.8
• Mean Change in OSDI Score From Baseline to Month 1 (Secondary), Mean, units on a scale: TearCare -13.7 +/- 12.5; Warm Compress & Lid Massage -10.0 +/- 7.7

Adverse events

Time frame: 6 months

• Study Protocol and Statistical Analysis Plan (PDF, 2018-03-16)

• Jaime Dickerson, PhD, Study director, Sight Sciences, Inc.