Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07365735
Brief Summary:
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).
Detailed Description:
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:
NCT07365735
Study Brief:
Protocol Section:
NCT07365735