To demonstrate the safety and effectiveness of TearCare® procedures compared to Restasis® to treat the signs and symptoms of dry eye disease in adult patients.
In this prospective, multicenter, randomized, active-controlled trial, TearCare is compared to cyclosporine 0.05% ophthalmic emulsion (Restasis) in eyes with dry eye disease (DED). Subjects randomized to TearCare receive TearCare treatment at baseline and Month 5, while subjects randomized to Restasis dose twice-daily with Restasis from baseline through Month 6. Primary inference is based on outcomes at the Month 6 visit including the co-primary endpoints tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
345
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 will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At the Month 6 visit subjects will stop Restasis and receive a single TearCare treatment.
Doctor My Eyes
Scottsdale, Arizona, United States
Scripps Health
La Jolla, California, United States
Harvard Eye Associates
Laguna Hills, California, United States
Tear Break-Up Time
Change in Tear Break-Up Time (TBUT) from baseline to month 6
Time frame: 6 months
OSDI Score
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.
Time frame: 6 months
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