This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant MGD. Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28. The primary objective is to evaluate the safety and efficacy of TearCare® in teenage and young-adult patients with MGD. A secondary objective includes a predictive analysis to determine which baseline clinical parameters best predict success with a TearCare treatment. Co-primary efficacy endpoints include change from baseline in non-invasive keratograph break-up time (NIKBUT) at Day 28 and change from baseline in ocular surface disease index (OSDI) at Day 28. Secondary endpoints include the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. Exploratory endpoints include change from baseline in Dry Eye-Related Quality of Life Score (DEQS) at Day 28. The primary safety endpoint is the incidence of adverse effects that are probably or definitely related to the intervention. The study population will include 45 young adults with clinically significant MGD (30 participants who are ≥18 to \<22 years of age and 15 participants who are ≥22 to \<30 years of age). The study duration is 4 weeks. TearCare® eyelid warming and manual gland expression will be performed once at Visit 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The TearCare system is designed to deliver controlled, precise heat to the tarsal plates and underlying MGs of the eyelids for 15 minutes. The TearCare system is comprised of a reusable SmartHub and single-use SmartLids. The single-use SmartLid pair comprises four flexible, sensor-controlled strips that adhere to each of the four eyelids. They contain flexible circuits, sensors, and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. The SmartLids are connected to the SmartHub. When attached to the SmartHub, the SmartLids deliver thermal energy (i.e., heat) to the eyelids. Embedded software and a closed loop sensor system ensures that the temperature delivered at the eyelids is maintained within a precise range.
University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
Birmingham, Alabama, United States
OSDI AT 4 WEEKS
The OSDI is a 12-item questionnaire that queries a patient's symptom frequency, situational context, and environmental triggers.
Time frame: Baseline to 4 weeks
Non-Invasive Keratograph Break-Up Time(NIKBUT) at 4 weeks
The secondary efficacy endpoint is the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. A clinically meaningful improvement in NIKBUT is defined as at least a 2-second increase versus baseline or at least a 50% increase15 if baseline NIKBUT \<4 s. A clinically meaningful improvement in OSDI is defined as a decrease of 4.5 units for mild to moderate disease16 (OSDI ≥ 13 by \<33 at baseline) or 7.3 units for severe disease16 (OSDI ≥ 33 at baseline)
Time frame: Baseline to Week 4
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