Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Design Validation of Senofilcon A With New UV-blocking Additive

15 listopada 2019 zaktualizowane przez: Johnson & Johnson Vision Care, Inc.
This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

253

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Cupertino, California, Stany Zjednoczone, 95014
        • James T. Fujimoto, OD
    • Florida
      • Maitland, Florida, Stany Zjednoczone, 32751
        • Maitland Vision Center
      • Tallahassee, Florida, Stany Zjednoczone, 32308
        • Tallahassee Eye Center
    • Illinois
      • Bloomington, Illinois, Stany Zjednoczone, 61701
        • Eyecare Associates LLP
    • Kansas
      • Pittsburg, Kansas, Stany Zjednoczone, 66762
        • Kannarr Eye Care
    • Ohio
      • Granville, Ohio, Stany Zjednoczone, 43023
        • Procare Vision Centers
      • Westerville, Ohio, Stany Zjednoczone, 43081
        • Professional Vision Care, Inc
    • Tennessee
      • Memphis, Tennessee, Stany Zjednoczone, 38111
        • Bradley Hines, OD
    • Texas
      • Tyler, Texas, Stany Zjednoczone, 75703
        • Frazier Vision, Inc
    • Wisconsin
      • New Berlin, Wisconsin, Stany Zjednoczone, 53151
        • Ziegler Leffingwell Eyecare

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 49 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

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

    1. The subject must 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. Between 18 and 49 (inclusive) years of age at the time of informed consent.
    4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision.
    5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
    6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
    7. Subjects must own a wearable pair of distance spectacles.
    8. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
    9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.

    10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 or better in each eye.

      Exclusion Criteria:

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

    1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
    2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
    3. Subjects taking suspect oral medications for less than one year.
    4. Any prescribed or over the counter (OTC) ocular medication.
    5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
    6. Toric, extended wear, monovision or multi-focal contact lens correction.
    7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.).
    8. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
    9. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
    10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    11. Binocular vision abnormality or strabismus by self-report or prior medical history.
    12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
    13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study.
    14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
    15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: senofilcon A TEST Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the TEST Lens for the duration of the clinical study.
Urządzenie: senofilcon A TEST Lens
JJVC Investigational Contact Lens
Aktywny komparator: senofilcon A CONTROL Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the CONTROL Lens for the duration of the clinical study.
Urządzenie: senofilcon A CONTROL Lens
Acuvue Oasys

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Comfort Score
Ramy czasowe: 2-Week Follow-up Evlauation
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Vision Satisfaction in Bright Lighting
Ramy czasowe: 2-Week Follow-up Evaluation
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type.
2-Week Follow-up Evaluation
Distance Visual Acuity
Ramy czasowe: 2-Week Follow-up Evlauation
Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.
2-Week Follow-up Evlauation
Contact Lens Fitting Acceptance Rate
Ramy czasowe: Up to 2-Week Follow-up

Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria:

  • limbal exposure at primary gaze or with extreme eye movement;
  • edge lift;
  • excessive movement in primary up gaze;
  • insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.

Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint.
Up to 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
Ramy czasowe: Up to 2-Week Follow-up Evlauation
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with 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). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.
Up to 2-Week Follow-up Evlauation

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Handling Score
Ramy czasowe: 2-Week Follow-up Evlauation
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Overall Quality of Vision Score
Ramy czasowe: 2-Week Follow-up Evlauation
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Johnson & Johnson Vision Care, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 października 2018

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2018

Ukończenie studiów (Rzeczywisty)

1 listopada 2018

Daty rejestracji na studia

Pierwszy przesłany

12 października 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 października 2018

Pierwszy wysłany (Rzeczywisty)

16 października 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 grudnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 listopada 2019

Ostatnia weryfikacja

1 listopada 2019

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • CR-6305

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na senofilcon A TEST Lens

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Ghana

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj