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TearCare in Young Adults

4. mai 2026 oppdatert av: Jillian Ziemanski, University of Alabama at Birmingham
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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Sindhu Gurrala, BDS, MPH
  • Telefonnummer: 205-975-3881
  • E-post: SOeyes@uab.edu

Studer Kontakt Backup

  • Navn: UAB Optometry Clinical Research (205) 934-6734
  • E-post: SOeyes@uab.edu

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jillian F Ziemanski, OD, PhD, FAAO

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
OSDI AT 4 WEEKS
Tidsramme: Baseline to 4 weeks
The OSDI is a 12-item questionnaire that queries a patient's symptom frequency, situational context, and environmental triggers.
Baseline to 4 weeks
Non-Invasive Keratograph Break-Up Time(NIKBUT) at 4 weeks
Tidsramme: 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)
Baseline to Week 4

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Samarbeidspartnere

Sight Sciences, Inc.

Etterforskere

  • Hovedetterforsker: Jillian F Ziemanski, OD, PhD, FAAO, The University of Alabama at Birmingham, School of Optometry

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 300016555
  • Sight Sciences, Inc. (Annen identifikator: Sight Sciences, Inc.)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared outside of the study team, sponsor, or regulatory agencies. Participant data will be used only for analysis related to this study and may be reviewed by authorized representatives of the sponsor (Sight Sciences, Inc.), the University of Alabama at Birmingham Institutional Review Board (IRB), and regulatory authorities as required by law. De-identified summary results may be shared in aggregate form in publications or presentations, but no individual-level data will be made publicly available.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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