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Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal

27. august 2026 opdateret af: Johnson & Johnson Vision Care, Inc.
This study is a 4-visit, multi-site, prospective, controlled, randomized, single-masked (subjects), two-arm parallel group, bilateral, dispensing clinical trial to compare the performance of the Test lens to the Control lens in terms of safety and efficacy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Longwood, Florida, Forenede Stater, 32779
        • Pearson Research Center PA
    • Georgia
      • Roswell, Georgia, Forenede Stater, 30076
        • VisualEyes
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63144
        • The Koetting Associates
    • New York
      • Jamestown, New York, Forenede Stater, 14701
        • Spectrum Eyecare
      • Manhattan, New York, Forenede Stater, 10022
        • Center for Ophthalmic and Vision Research/Eye Associates of New York
      • Vestal, New York, Forenede Stater, 13850
        • Sacco Eye Group
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02888
        • Dr. David W. Ferris & Associates
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Total Eye Care
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Paradigm Research Center, LLC
      • Tyler, Texas, Forenede Stater, 75703
        • Tyler Eye Associates
    • Virginia
      • Salem, Virginia, Forenede Stater, 24153
        • Botetourt Eyecare, LLC

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

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 at least 40 years of age and not greater than 70 years of age at the time of consent.
  4. Own a wearable pair of spectacles if required for their distance vision.
  5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 30 days or more duration).
  6. Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
  7. The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.50 D to -5.50 D in each eye.
  8. The subject's refractive cylinder must be ≤0.75 D in each eye.
  9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
  10. The subject must have distance best corrected visual acuity of 0.0 logMAR (20/20 Snellen, 5.0 on the China standard 5-point logMAR visual acuity scale) or better in each eye.

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

  1. Be currently pregnant or lactating.
  2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  3. Have been diagnosed with diabetes.
  4. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
  5. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
  6. Have a history of amblyopia, strabismus or binocular vision abnormality.
  7. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids.
  8. Use of any ocular medication.
  9. Have a history of herpetic keratitis.
  10. Have a history of irregular cornea.
  11. Have a history of pathological dry eye.
  12. Have a history of glaucoma or glaucoma suspect.
  13. Have a history of any retinal disease/condition that may interfere with any of the study assessments or are not stable and have potential to progress during the study.
  14. Have participated in any contact lens or lens care product clinical trial within 15 days prior to study enrollment.
  15. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild, sibling of the employee or their spouse) of the clinical site.
  16. Have any known hypersensitivity or allergic reaction to sodium fluorescein.
  17. Have Grade 3 or greater palpebral conjunctival observations or Grade 2 or greater slit lamp findings (e.g. corneal edema, corneal vascularization, corneal staining, bulbar injection, etc.) on the ISO 11980 classification scale, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  18. Have any current ocular infection or inflammation.
  19. Have intraocular pressure in one or both eyes >21mmHg
  20. Have signs of any retinal disease/conditions that may interfere with any of the study assessments or are not stable and have potential to progress during the study.

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: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Senofilcon A
Eligible subjects will be randomized to the Senofilcon A Lens for the duration of the study.
Enhed: Senofilcon A
ACUVUE® Oasys MAX 1-Day Multifocal
Aktiv komparator: Nelfilcon A
Eligible subjects will be randomized to the Nelfilcon A Lens for the duration of the study.
Enhed: Nelfilcon A
DAILIES® AquaComfort Plus® Multifocal

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean binocular HLHC distance Visual Acuity
Tidsramme: At 1-week follow-up
Mean binocular HLHC VA at distance (4m)
At 1-week follow-up
Mean binocular HLHC Intermediate Visual Acuity
Tidsramme: At 1-week follow-up
Mean binocular HLHC VA at Intermediate (64cm)
At 1-week follow-up
Mean binocular HLHC Near Visual Acuity
Tidsramme: At 1-week follow-up
Mean binocular HLHC VA at Near (40cm)
At 1-week follow-up
Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.
Tidsramme: Up to 1-month follow-up
Up to 1-month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean binocular HLHC distance Visual Acuity
Tidsramme: At 1-month follow-up
Mean binocular HLHC VA at distance (4m)
At 1-month follow-up
Mean binocular HLHC Intermediate Visual Acuity
Tidsramme: At 1-month follow-up
Mean binocular HLHC VA at Intermediate (64cm)
At 1-month follow-up
Mean binocular HLHC Near Visual Acuity
Tidsramme: At 1-month follow-up
Mean binocular HLHC VA at Near (40cm)
At 1-month follow-up
Incidence rate of Slit Lamp Findings (SLF)
Tidsramme: Up to 1-month follow-up
Slit lamp findings will be assessed for each eye at all study visits (scheduled and unscheduled) by grade. SLFs will be evaluated and graded using the ISO 11980 Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e., Grade 1 = trace, Grade 2 = mild, Grade 3 = moderate and Grade 4 = severe).
Up to 1-month follow-up

Samarbejdspartnere og efterforskere

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

Sponsor

Johnson & Johnson Vision Care, Inc.

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 (Anslået)

28. august 2026

Primær færdiggørelse (Anslået)

11. december 2026

Studieafslutning (Anslået)

11. december 2026

Datoer for studieregistrering

Først indsendt

23. august 2026

Først indsendt, der opfyldte QC-kriterier

23. august 2026

Først opslået (Faktiske)

26. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CR-6560

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 .

Abonner