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Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist

19. juli 2020 opdateret af: CooperVision, Inc.
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

43

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85032
        • Phoenix Eye Care, PLLC
    • Illinois
      • Lake Zurich, Illinois, Forenede Stater, 60047
        • Lake Zurich Eye Care
    • Ohio
      • Athens, Ohio, Forenede Stater, 45701
        • Drs. Quinn, Foster & Assoc.
      • New Albany, Ohio, Forenede Stater, 43054
        • Vision Professionals

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

Beskrivelse

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 40 years of age (inclusive)
  • Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft CL (Contact Lens) wearer
  • Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so
  • Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
  • Has less than 0.75D (Diopters) spectacle cylinder in each eye.
  • Is correctable to a visual acuity of 20/25 or better in both eyes
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Is willing to comply with the wear schedule (at least 40 hrs per week)
  • Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Has never worn contact lenses before.
  • Currently wears rigid gas permeable contact lenses.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has a CL prescription outside the range of - 1.00 to -6.00D
  • Has a spectacle cylinder greater than -0.50D of cylinder in either eye.
  • Has best corrected spectacle distance vision worse then 20/25 in either eye.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars.
  • Is aphakic.
  • Is presbyopic.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research 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: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: omafilcon A
Study participants are randomized to wear omafilcon A lenses.
Enhed: omafilcon A
kontaktlinse
Andre navne:
  • Proclear 1 Day (omafilcon A)
Aktiv komparator: etafilcon A
Study participants are randomized to wear etafilcon A lenses.
Enhed: etafilcon A
kontaktlinse
Andre navne:
  • 1-dages Acuvue Moist (etafilcon A)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comfort (Subjective Assessment)
Tidsramme: Baseline
Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Baseline
Comfort (Subjective Assessment)
Tidsramme: 1 Week
Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
1 Week
Hydration (Subjective Assessment)
Tidsramme: Baseline
Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Baseline
Hydration (Subjective Assessment)
Tidsramme: 1 Week
Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
1 Week
Vision Quality (Subjective Assessment)
Tidsramme: Baseline
Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)
Baseline
Vision Satisfaction (Subjective Assessment)
Tidsramme: 1 Week
Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)
1 Week
Dryness (Subjective Assessment)
Tidsramme: 1 Week
Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)
1 Week
Handling (Subjective Assessment)
Tidsramme: 1 Week
Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)
1 Week
Eye Whiteness/Redness (Subjective Assessment)
Tidsramme: 1 Week
Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)
1 Week
Overall Sensation of Smoothness (Subjective Assessment)
Tidsramme: 1 Week
Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)
1 Week
Overall Satisfaction for Lens
Tidsramme: 1 Week
Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)
1 Week

Samarbejdspartnere og efterforskere

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

Sponsor

CooperVision, Inc.

Efterforskere

  • Ledende efterforsker: Donald Siegel, OD, Sun City West Eye Care

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

1. januar 2014

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

27. december 2013

Først indsendt, der opfyldte QC-kriterier

27. december 2013

Først opslået (Skøn)

31. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EX-MKTG-43

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 Nærsynethed

Kliniske forsøg med etafilcon A

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner