TearCare in Young Adults
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sindhu Gurrala, BDS, MPH
- 電話番号：205-975-3881
- メール：SOeyes@uab.edu
研究連絡先のバックアップ
- 名前：UAB Optometry Clinical Research (205) 934-6734
- メール：SOeyes@uab.edu
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
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コンタクト：
- Sindhu Gurrala, BDS, MPH
- 電話番号：205-975-3881
- メール：sgurral2@uab.edu
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主任研究者：
- Jillian F Ziemanski, OD, PhD, FAAO
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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OSDI AT 4 WEEKS
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Jillian F Ziemanski, OD, PhD, FAAO、The University of Alabama at Birmingham, School of Optometry
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 300016555
- Sight Sciences, Inc. (その他の識別子：Sight Sciences, Inc.)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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