- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02024698
Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
19. juli 2020 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
43
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85032
- Phoenix Eye Care, PLLC
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Illinois
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Lake Zurich, Illinois, Forente stater, 60047
- Lake Zurich Eye Care
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Ohio
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Athens, Ohio, Forente stater, 45701
- Drs. Quinn, Foster & Assoc.
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New Albany, Ohio, Forente stater, 43054
- Vision Professionals
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 40 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: omafilcon A
Study participants are randomized to wear omafilcon A lenses.
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kontaktlinse
Andre navn:
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Aktiv komparator: etafilcon A
Study participants are randomized to wear etafilcon A lenses.
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kontaktlinse
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comfort (Subjective Assessment)
Tidsramme: Baseline
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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)
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Baseline
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Comfort (Subjective Assessment)
Tidsramme: 1 Week
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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)
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1 Week
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Hydration (Subjective Assessment)
Tidsramme: Baseline
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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)
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Baseline
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Hydration (Subjective Assessment)
Tidsramme: 1 Week
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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)
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1 Week
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Vision Quality (Subjective Assessment)
Tidsramme: Baseline
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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)
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Baseline
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Vision Satisfaction (Subjective Assessment)
Tidsramme: 1 Week
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Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= very unsatisfied, 10=very satisfied)
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1 Week
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Dryness (Subjective Assessment)
Tidsramme: 1 Week
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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)
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1 Week
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Handling (Subjective Assessment)
Tidsramme: 1 Week
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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)
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1 Week
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Eye Whiteness/Redness (Subjective Assessment)
Tidsramme: 1 Week
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Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale.
(0-10; 0= significant redness, 10=totally white)
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1 Week
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Overall Sensation of Smoothness (Subjective Assessment)
Tidsramme: 1 Week
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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)
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1 Week
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Overall Satisfaction for Lens
Tidsramme: 1 Week
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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)
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1 Week
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Donald Siegel, OD, Sun City West Eye Care
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2014
Primær fullføring (Faktiske)
1. januar 2014
Studiet fullført (Faktiske)
1. mars 2014
Datoer for studieregistrering
Først innsendt
27. desember 2013
Først innsendt som oppfylte QC-kriteriene
27. desember 2013
Først lagt ut (Anslag)
31. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juli 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juli 2020
Sist bekreftet
1. juli 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EX-MKTG-43
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .