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Dynamic Characterisation of Meibomian Gland Structure

16. juli 2021 opdateret af: Johnson & Johnson Vision Care, Inc.
This will be a single center pilot study to evaluate appearance of the Meibomian glands.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

25

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria

Beskrivelse

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. Healthy adult males and females, 18-40 years of age (inclusive)
    2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
    3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
    4. The subject must agree not to participate in other clinical research for the duration of this study
    5. The subject's optimal spherical equivalent distance refraction must be between +1.00 and -2.00 D in each eye
    6. The subject's refractive cylinder must be ≤-1.00 DC in each eye
    7. The subject must score less than 4 points (inclusive) in SPEED questionnaire

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently pregnant or lactating
    2. Any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g. hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g. HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study
    3. Have had cataract surgery
    4. Use of systemic medications (e.g. chronic steroid use) and any current use of ocular medications (e.g. lubricants, artificial tears) that would interfere with participation in the trial, at the Investigator's discretion
    5. They have history (more than one week in total) of contact lens wear.
    6. Any previous, or planned (during the course of the study) ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
    7. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, corneal distortion or keratoconus
    8. History of allergy to sodium fluorescein or lissamine green
    9. Any Grade 1.5 or greater slit lamp findings (e.g. oedema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron Grading Scales or other ocular abnormality including Meibomian gland dysfunction (MGD) or blepharitis (Grade 1.0 or greater)
    10. Meibomian gland atrophy exceeds 25% (inclusive) in either lower or upper eyelid
    11. The central glands atrophy exceeds 25% (inclusive)
    12. The number of Meibomian glands yielding liquid secretion (MGYLS) is 6 or less (applicable to Phase II subjects only)
    13. Use of eye makeup on the days of the study visits
    14. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrolment
    15. Employee or immediate family member of an employee of clinical site (e.g. Investigator, Coordinator, Technician)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Experimental
Eligible subjects will undergo repeated observations to evaluate the Meibomian gland appearance

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Meibomian Gland Appearance - Area
Tidsramme: up to 4-week follow-up
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the area corresponding to individual and aggregated Meibomian glands.
up to 4-week follow-up
Meibomian Gland Appearance - Mean Reflectivity
Tidsramme: up to 4-week follow-up
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the mean reflectivity of individual and aggregated Meibomian glands
up to 4-week follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lipid Layer Thickness (LLT)
Tidsramme: up to 4-week follow-up
LLT will be measured using the LipiView® II instrument on the right eye only.
up to 4-week follow-up
Non-Invasive Tear Break-Up Time (NIBUT)
Tidsramme: up to 4-week follow-up
NIBUT will be evaluated using the Medmont E300 instrument, with three measurements taken for the right eye only, at least 30 seconds apart and the median recorded.
up to 4-week follow-up
Tear Film Evaporation Rate
Tidsramme: up to 4-week follow-up
Tear film evaporation rate will be assessed using the Eye-VapoMeter for 3 consecutive open eye measurements followed by 3 consecutive closed eye measurements. The mean for each method will be calculated.
up to 4-week follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. oktober 2020

Primær færdiggørelse (Faktiske)

22. juni 2021

Studieafslutning (Faktiske)

22. juni 2021

Datoer for studieregistrering

Først indsendt

9. november 2020

Først indsendt, der opfyldte QC-kriterier

25. november 2020

Først opslået (Faktiske)

2. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CR-6369

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Synsstyrke

3
Abonner