TearCare is an office-based thermal therapeutic eyelid technology cleared by the US Food and Drug Administration for the treatment of evaporative dry eye disease due to meibomian gland dysfunction. In this randomized study, TearCare procedures using the TearCare MGX System (study device) with the extended Warming hold feature will be compared with TearCare procedures using the TearCare MGX System without the Warming hold (control group).
This study will collect data to assess the clinical utility of the Warming Hold period. The TearCare MGX Warming hold is a 10-minute period beyond completion of the Core Therapy time that serves to preserve elevated temperature by outputting only enough energy to maintain heat at the lowest setting of the system. At the minimum warmth setting the SmartLid device surfaces provide a steady state temperature of 39.0°C. This is a prospective, randomized, assessor-masked, single-center, non-significant risk (NSR) study. To reduce potential bias in the study, study staff performing the endpoint assessments will be masked. Subjects will also be masked as to group assignment. In this randomized study, TearCare procedures using the TearCare MGX System (study device) with the extended Warming hold feature will be compared with TearCare procedures using the TearCare MGX System without the Warming hold (control group). 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 will receive one in-office TearCare procedure at the Procedure Visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Blink-assisted, open eye therapy. Heat (45 degrees C) applied for 15 minutes to the upper and lower eyelids, followed by manual expression of the meibomian glands.
Cleveland Eye Clinic
Brecksville, Ohio, United States
Mean difference between eyes in Meibomian Gland Secretion Score (MGSS)
The Meibomian Gland Secretion Score (MGSS) grades the consistency of secretions from the meibomian glands. 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 The difference between eyes in the MGSS is the score for the right eye minus the score for the left eye. The mean is the arithmetic mean of this difference for all subjects.
Time frame: MGSS used to calculate the difference in MGSS between eyes is obtained post-treatment at the procedure visit (Day 0).
Mean change from Screening visit baseline in MGSS
The Meibomian Gland Secretion Score (MGSS) grades the consistency of secretions from the meibomian glands. 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 The change from baseline in the MGSS is the score obtained following treatment at the procedure visit minus the score obtained for the same eye at the Screening visit. The mean is the arithmetic mean of this difference for all eyes.
Time frame: MGSS is assessed at the Screening visit (Day -30 to Day -7) and at the Procedure visit (Day 0)
Mean change from Screening visit baseline in Meibomian Glands Yielding Any Liquid (MGYAL)
The Meibomian glands yielding any liquid (MGYAL) is the number of glands in the lower eyelid secreting any liquid, (regardless of graded quality). The score can range from 0 (no glands secreting liquid), to 15 (all 15 glands with liquid secreted). A higher score is better. The mean change from Screening visit baseline is the mean difference between the MGYAL at screening and the MGYAL post-procedure at the procedure visit.
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Time frame: MGYAL is assessed at the Screening visit (Day -30 to -7) and at the Procedure visit (Day 0)
Mean change from Screening visit baseline in Meibomian Glands Yielding Clear Liquid (MGYCL)
The Meibomian glands yielding clear liquid (MGYCL) is the number of glands in the lower eyelid secreting clear liquid. The score can range from 0 (no glands secreting clear liquid), to 15 (all 15 glands with clear liquid secreted). A higher score is better. The mean change from Screening visit baseline is the mean difference between the MGYCL at screening and the MGYCL post-procedure at the procedure visit.
Time frame: MGYCL is assessed at the Screening visit (Day -30 to Day -7) and post-treatment at the Procedure visit (Day 0)
Subject Comfort during expression of second lid
Subject Comfort during expression of second lid is assessed following treatment using a subject completed Likert scale rating the relative comfort of eyelid gland expression for the first lid expressed versus the second.
Time frame: Subject Comfort during expression of second lid is assessed post-treatment at the Procedure visit (Day 0)
Ease of expression
Ease of expression is assessed following treatment using a masked-assessor completed Likert scale rating the relative ease of eyelid gland expression for the first lid expressed versus the second.
Time frame: Ease of expression is assessed following treatment at the Procedure visit (Day 0)