TearCare in Young Adults

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство TearCare®
  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 gla

Первичные конечные точки

• OSDI AT 4 WEEKS [Срок оценки: Baseline to 4 weeks]
• Non-Invasive Keratograph Break-Up Time(NIKBUT) at 4 weeks [Срок оценки: Baseline to Week 4]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Use of any of the following medications within 60 days of enrollment:

• Topical ophthalmic cyclosporine (including but not limited to Restasis®, Cequa®, Vevye®, generic, or compounded versions)
• Xiidra®
• Miebo®
• Tyrvaya®
• Tryptyr®
• Use of topical ocular steroids within 30 days of enrollment
• Use of any other topical ophthalmic drop, excluding artificial tears, within 7 days
• Use of oral tetracyclines or oral azithromycin within 30 days
• Present or past use of oral isotretinoin
• Any of the following procedural treatments for MGD in the past:

• LipiFlow®
• TearCare®
• iLux®
• Intense pulsed light (IPL)
• Previous intraocular surgery within 6 months of enrollment
• Previous refractive surgery within 2 years of enrollment
• Current or planned pregnancy during the study period
• Current or planned lactation during the study period
• Females of childbearing potential who are not using effective contraception
• Dose modification of oral antihistamines or antidepressants within 30 days of enrollment
• Current enrollment or enrollment within 60 days in any other study of an investigational drug or device
• Clinical opinion of the study doctor based on clinical examination and/or participant compliance with protocol requirements

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility — Birmingham

Идентификаторы

NCT: NCT07579156 · 300016555 · Sight Sciences, Inc.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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