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Dispensing Evaluation of Investigational Contact Lenses

5. mai 2017 oppdatert av: Johnson & Johnson Vision Care, Inc.
Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

177

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Florida
      • Jacksonville, Florida, Forente stater, 32250
        • Edward S. Wygonik, OD
      • Pembroke Pines, Florida, Forente stater, 33024
        • The Eye Center
      • Winter Park, Florida, Forente stater, 32792
        • Eye Associates of Winter Park
    • Illinois
      • Bloomington, Illinois, Forente stater, 61701
        • Eyecare Associates
    • Indiana
      • Bloomington, Indiana, Forente stater, 47405
        • Indiana University College of Optometry
    • Kansas
      • Pittsburg, Kansas, Forente stater, 66762
        • Kannarr Eye Care
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87109
        • ABQ Eyecare
    • New York
      • Vestal, New York, Forente stater, 13850
        • Sacco Eye Group
    • Ohio
      • Springfield, Ohio, Forente stater, 45503
        • New Image Eye Center
      • Westerville, Ohio, Forente stater, 43081
        • Professional Vision Care
    • Rhode Island
      • Warwick, Rhode Island, Forente stater, 02888
        • West Bay Eye Associates
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38119
        • Total Eye Care PA

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 39 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
  • The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
  • Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
  • Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye.
  • Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye.
  • If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction.
  • Subject's best corrected distance acuity must be 20/25-2 or better in each eye.

Exclusion Criteria:

  • Females who are currently pregnant or lactating.
  • Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
  • Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
  • Habitual wearer of extended wear contact lenses.
  • Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
  • History of seizures.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report.
  • History of binocular vision abnormality or strabismus, by self-report.
  • Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
  • Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
  • Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  • Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale.
  • Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
  • Any active ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Prototype toric lens senofilcon A
Subjects will wear the senofilcon A prototype toric contact lens bilaterally for 6-8 days as a daily disposable modality.
Enhet: Prototype toric lens senofilcon A
Investigational prototype

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
Tidsramme: 7 day follow-up
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
7 day follow-up
The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Tidsramme: 15 Minutes Post Insertion
Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.
15 Minutes Post Insertion
Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
Tidsramme: 15 Minutes Post Insertion
Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.
15 Minutes Post Insertion
Proportion of Subject Eyes With Acceptable Lens Fit
Tidsramme: 15 Minute Post Insertion
Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.
15 Minute Post Insertion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johnson & Johnson Vision Care, Inc.

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. oktober 2015

Primær fullføring (Faktiske)

1. november 2015

Studiet fullført (Faktiske)

1. november 2015

Datoer for studieregistrering

Først innsendt

3. november 2015

Først innsendt som oppfylte QC-kriteriene

4. desember 2015

Først lagt ut (Anslag)

9. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2017

Sist bekreftet

1. mai 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR-5769

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