TearRestore, Inc. announced positive results from a recent clinical trial of the TearRestore eyelid warming mask.
Talk about the participants first.
The study (NCT04309799) included adults between age 18 and 89 diagnosed with meibomian gland dysfunction (MGD), a SPEED score of >8, <75 nm lipid layer thickness (LLT), and <10 second tear breakup time (TBUT).
Now tell me about the trial.
The trial was conducted at University of Colorado, Denver and led by principal investigator and medical advisor to TearRestore, Scott G. Hauswirth, OD, FAAO. Twenty-two eyes were enrolled in the primary arm of the study. An undisclosed number elected to continue with the optional extension, where they extended daily use of the mask for a period of 28 to 60 days, recording each use in a diary.
Patients completed a SPEED questionnaire prior to using the TearRestore mask, and then again after a 10-minute session with the mask.
The primary outcome measures included the SPEED questionnaire, with secondary outcome measures tracking LLT, TBUT, and the number of meibomian glands yielding liquid secretions.
What did they find?
In the initial reports of study data, TearRestore reported that SPEED questionnaire results were reduced by 51% after the first 10-minute treatment, and by 34% from baseline after the 28 to 60-day extension period.
TBUT increased by 90% after the first treatment and 80% from baseline after 30-60 days; the number of meibomian glands yielding liquid secretions increased by 40% after initial treatment and 28% from baseline after 30-60 days, respectively.
The topline data released did not include a report of the lipid layer thickness outcomes.
The take home.
This trial offers promising data for the performance of a widely available product for MGD, while the small sample size calls for further research.