Meibomian Gland Dysfunction (Disorder)
Conditions
Keywords
Meibomian Gland Dysfunction, TearCare, Ocular Surface Inflammation, Dry Eye Disease
Brief summary
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.
Detailed description
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.
Interventions
DEVICETearCare®
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.
Sponsors
University of Alabama at Birmingham
Sight Sciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
All participants, investigators, and study staff will know the treatment being administered. No masking or blinding procedures are implemented.
Intervention model description
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
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years but \<30 years of age 2. Non-invasive Keratograph break-up time (NIKBUT) \<10 seconds in at least one eye 3. Meibomian gland secretion score (MGSS) ≤23 for 15 glands in at least one eyelid 4. OSDI ≥23
Exclusion criteria
1. Contact lens wear within two weeks of study enrollment or planned during study period 2. Habitual visual acuity worse than 0.30 logMAR (Snellen equivalent of 20/40) in either eye 3. Previous or current diagnosis of any autoimmune condition 4. Use of any of the following medications within 60 days of enrollment: 1. Topical ophthalmic cyclosporine (including but not limited to Restasis®, Cequa®, Vevye®, generic, or compounded versions) 2. Xiidra® 3. Miebo® 4. Tyrvaya® 5. Tryptyr® 5. Use of topical ocular steroids within 30 days of enrollment 6. Use of any other topical ophthalmic drop, excluding artificial tears, within 7 days 7. Use of oral tetracyclines or oral azithromycin within 30 days 8. Present or past use of oral isotretinoin 9. Any of the following procedural treatments for MGD in the past: 1. LipiFlow® 2. TearCare® 3. iLux® 4. Intense pulsed light (IPL) 10. Previous intraocular surgery within 6 months of enrollment 11. Previous refractive surgery within 2 years of enrollment 12. Current or planned pregnancy during the study period 13. Current or planned lactation during the study period 14. Females of childbearing potential who are not using effective contraception 15. Dose modification of oral antihistamines or antidepressants within 30 days of enrollment 16. Current enrollment or enrollment within 60 days in any other study of an investigational drug or device 17. Clinical opinion of the study doctor based on clinical examination and/or participant compliance with protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSDI AT 4 WEEKS | Baseline to 4 weeks | The OSDI is a 12-item questionnaire that queries a patient's symptom frequency, situational context, and environmental triggers. |
| Non-Invasive Keratograph Break-Up Time(NIKBUT) at 4 weeks | Baseline to Week 4 | 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) |
Countries
United States
Contacts
CONTACTSindhu Gurrala, BDS, MPH
CONTACTUAB Optometry Clinical Research (205) 934-6734
PRINCIPAL_INVESTIGATORJillian F Ziemanski, OD, PhD, FAAO
The University of Alabama at Birmingham, School of Optometry
Outcome results
None listed