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Evaluering af effekten af spredning på visuel præstation

24. september 2026 opdateret af: Johnson & Johnson Vision Care, Inc.

Evaluering af spredningens effekt på visuel præstation

This will be a 3-visit, single-site, randomized, single-masked, bilateral wear, non-dispensing, crossover study which will evaluate visual performance with different magnitudes of scatter.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Optical scatter may affect young adults or non-presbyopes and older adults or presbyopes differently. Intrinsic ocular scatter increases with age and ocular scatter sensitivity as well as profile is different in younger adults and older adults.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Florida
      • Jacksonville, Florida, Forenede Stater, 32256
        • VRC

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 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

  1. Read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 69 years of age (inclusive) at the time of screening.
  4. Habitually wear soft contact lenses (either spherical or multifocal) in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days.
  5. Possess a wearable pair of spectacles that provide correction for distance vision.
  6. Have the spherical component of their vertex-corrected distance refraction within the range +3.00 to -5.00 DS (inclusive) in both eyes.
  7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 1.00 DC in both eyes.
  8. Have best corrected monocular distance VA of 20/25 or better in each eye.
  9. Have Near Addition with Add refinement following BCC<0.75D (Non-presbyopic group only).
  10. Have Near Addition with Add refinement following BCC≥0.75D (Presbyopic group only).

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

  1. Be currently pregnant or lactating.
  2. Be diabetic.
  3. Be currently using any ocular medications or have an ocular infection of any type.
  4. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications.
  5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
  6. Be currently wearing lenses in an extended wear modality.
  7. Have a history of strabismus or amblyopia.
  8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
  9. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  10. Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
  11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  12. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm

Eligible subjects will be randomly assigned to the No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm sequence

Lens for non-Presbyopes

Lens for Prebyopes

Eksperimentel: Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter

Eligible subjects will be randomly assigned to the Filter 1/4mm/Filter 1/2mm/Filter 1mm/Filter 2mm/No filter sequence

Lens for non-Presbyopes

Lens for Prebyopes

Eksperimentel: Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm

Eligible subjects will be randomly assigned to the Filter 1/2mm/Filter 1mm/Filter 2mm/No filter/Filter 1/4mm sequence

Lens for non-Presbyopes

Lens for Prebyopes

Eksperimentel: Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm

Eligible subjects will be randomly assigned to the Filter 1mm/Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm sequence

Lens for non-Presbyopes

Lens for Prebyopes

Eksperimentel: Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm

Eligible subjects will be randomly assigned to the Filter 2mm/No filter/Filter 1/4mm/Filter 1/2mm/Filter 1mm sequence

Lens for non-Presbyopes

Lens for Prebyopes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distance Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA)
Tidsramme: Day 1 Post lens fitting

Distance (4 meters) Monocular High luminance high contrast (HLHC) logMAR Visual acuity (VA) without glare will be assessed after lens fitting.

Day 1 Post lens fitting

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Studieleder: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

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)

13. februar 2026

Primær færdiggørelse (Faktiske)

22. maj 2026

Studieafslutning (Faktiske)

22. maj 2026

Datoer for studieregistrering

Først indsendt

10. februar 2026

Først indsendt, der opfyldte QC-kriterier

27. februar 2026

Først opslået (Faktiske)

2. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CR-6626

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

Ja

produkt fremstillet i og eksporteret fra U.S.A.

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 .