TearCare in Young Adults
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sindhu Gurrala, BDS, MPH
- 전화번호: 205-975-3881
- 이메일: SOeyes@uab.edu
연구 연락처 백업
- 이름: UAB Optometry Clinical Research (205) 934-6734
- 이메일: SOeyes@uab.edu
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
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연락하다:
- Sindhu Gurrala, BDS, MPH
- 전화번호: 205-975-3881
- 이메일: sgurral2@uab.edu
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수석 연구원:
- Jillian F Ziemanski, OD, PhD, FAAO
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Treatment
TearCare® eyelid warming and manual gland expression performed once at Visit 1 and followed for 4 weeks.
All participants will undergo standardized ocular assessments including OSDI questionnaires, non-invasive keratograph break-up time, Visual acuity high contrast, Biomicroscopy, posterior lid margin hyperemia, Fluorescein tear breakup time, corneal fluorescein staining, conjunctival staining with lissamine green, lid wiper epitheliopathy with lissamine green, Surveys - DEQS, SANDE, Screen time-use, Lipview 11 lipid imaging, Keratograph R-scan, Keratogrpahy meibography, meiobomian gland expression by meibomian gland evaluator.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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OSDI AT 4 WEEKS
기간: Baseline to 4 weeks
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The OSDI is a 12-item questionnaire that queries a patient's symptom frequency, situational context, and environmental triggers.
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Baseline to 4 weeks
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Non-Invasive Keratograph Break-Up Time(NIKBUT) at 4 weeks
기간: Baseline to Week 4
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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)
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Baseline to Week 4
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jillian F Ziemanski, OD, PhD, FAAO, The University of Alabama at Birmingham, School of Optometry
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 300016555
- Sight Sciences, Inc. (기타 식별자: Sight Sciences, Inc.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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TearCare®에 대한 임상 시험
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Sight Sciences, Inc.완전한안구건조증 | 마이 봄선 기능 장애미국
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Chung-Ang University Hosptial, Chung-Ang University...알려지지 않은
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Novartis Pharmaceuticals완전한
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Guerbet완전한원발성 뇌종양콜롬비아, 대한민국, 미국, 멕시코