- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04649606
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
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Manchester, Det Forenede Kongerige, M13 9PL
- The University of Manchester
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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:
- Healthy adult males and females, 18-40 years of age (inclusive)
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
- The subject must agree not to participate in other clinical research for the duration of this study
- The subject's optimal spherical equivalent distance refraction must be between +1.00 and -2.00 D in each eye
- The subject's refractive cylinder must be ≤-1.00 DC in each eye
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:
- Currently pregnant or lactating
- 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
- Have had cataract surgery
- 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
- They have history (more than one week in total) of contact lens wear.
- Any previous, or planned (during the course of the study) ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- 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
- History of allergy to sodium fluorescein or lissamine green
- 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)
- Meibomian gland atrophy exceeds 25% (inclusive) in either lower or upper eyelid
- The central glands atrophy exceeds 25% (inclusive)
- The number of Meibomian glands yielding liquid secretion (MGYLS) is 6 or less (applicable to Phase II subjects only)
- Use of eye makeup on the days of the study visits
- Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrolment
- 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 |
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Experimental
Eligible subjects will undergo repeated observations to evaluate the Meibomian gland appearance
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Meibomian Gland Appearance - Area
Tidsramme: up to 4-week follow-up
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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.
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up to 4-week follow-up
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Meibomian Gland Appearance - Mean Reflectivity
Tidsramme: up to 4-week follow-up
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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
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up to 4-week follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Lipid Layer Thickness (LLT)
Tidsramme: up to 4-week follow-up
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LLT will be measured using the LipiView® II instrument on the right eye only.
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up to 4-week follow-up
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Non-Invasive Tear Break-Up Time (NIBUT)
Tidsramme: up to 4-week follow-up
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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.
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up to 4-week follow-up
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Tear Film Evaporation Rate
Tidsramme: up to 4-week follow-up
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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.
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up to 4-week follow-up
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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 .
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