TearCare in Young Adults

ConditionMeibomian Gland Dysfunction (Disorder)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-29

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years but <30 years of age

Non-invasive Keratograph break-up time (NIKBUT) <10 seconds in at least one eye

Meibomian gland secretion score (MGSS) ≤23 for 15 glands in at least one eyelid

OSDI ≥23

Disqualifiers

Contact lens wear within two weeks of study enrollment or planned during study period

Habitual visual acuity worse than 0.30 logMAR (Snellen equivalent of 20/40) in either eye

Previous or current diagnosis of any autoimmune condition

Topical ophthalmic cyclosporine (including but not limited to Restasis®, Cequa®, Vevye®, generic, or compounded versions)

Trial design

Design model

Single group

Treatments tested in this trial

TearCare®
Device
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.

Treatment groups

45 Participants

are divided into 1 treatment group

Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Sight Sciences, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: