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

Not Applicable

Terminated

Brief Summary: In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.

NOTE: All sites have been selected for this study.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (6): Harvard Eye Associates
🇺🇸
Laguna Hills, California, United States
Eye Research Foundation
🇺🇸
Newport Beach, California, United States
Center for Excellence in Eye Care
🇺🇸
Miami, Florida, United States
Cincinnati Eye Institute
🇺🇸
Edgewood, Kentucky, United States
Ophthalmology Associates
🇺🇸
St Louis, Missouri, United States
Vance Thompson Vision
🇺🇸
Sioux Falls, South Dakota, United States
Harvard Eye Associates
🇺🇸Laguna Hills, California, United States