Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Multicenter Dispensing Study of Biofinity Lenses in Extended Range

8. November 2017 aktualisiert von: CooperVision, Inc.
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

19

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Ontario
      • Waterloo, Ontario, Kanada, N2L 3G1
        • CCLR, University of Waterloo
  • Vereinigte Staaten
    • California
      • Berkeley, California, Vereinigte Staaten, 94720-2020
        • UC Berkeley Clinica Research Center
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46266-6057
        • CORL, Indiana University School of Optometry
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77204-2020
        • TERTC, University of Houston

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
  • Currently wears soft contact lenses
  • They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
  • Has clear corneas and no active ocular disease
  • Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

  • Has any systemic disease affecting ocular health
  • Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
  • Have any active ocular disease and/or infection that would contraindicate contact lens wear.
  • Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
  • Has worn gas permeable contact lenses within the last month.
  • Is aphakic
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of clinical research study
  • Female who is currently pregnant or is breast-feeding.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Biofinity XR
Participants dispensed Biofinity XR lenses over two weeks of lens wear
Gerät: Biofinity XR

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dryness (During Day and Dryness at Night)
Zeitfenster: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.
Baseline
Dryness (During Day)
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Dryness (During Day and Dryness at Night)
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.
2 Weeks
Comfort (Insertion, End of Day, Overall)
Zeitfenster: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Baseline
Comfort (Insertion)
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Comfort (Insertion, End of Day, Overall)
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
2 Weeks
Ghosting (Multiple Images)
Zeitfenster: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.
Baseline
Ghosting (Multiple Images)
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Ghosting (Multiple Images)
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.
2 Weeks
Hazing (Blurred Edges)
Zeitfenster: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.
Baseline
Hazing (Blurred Edges)
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.
2 Weeks
Vision Quality (During Day and at Night)
Zeitfenster: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.
Baseline
Vision Quality (During Day)
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Vision Quality (During Day and at Night)
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.
2 Weeks
Handling (Insertion, Removal, Overall)
Zeitfenster: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Baseline
Handling (Insertion, Removal, Overall)
Zeitfenster: 2 weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
2 weeks
Overall Satisfaction of Comfort, Vision, Handling
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Overall Satisfaction of Comfort, Vision, Handling
Zeitfenster: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.
Baseline
Overall Satisfaction of Comfort, Vision, Handling
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.
2 Weeks
Comfort Preference
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Comfort Preference
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks
Vision Preference
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Vision Preference
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks
Handling Preference
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks
Overall Preference
Zeitfenster: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Overall Preference
Zeitfenster: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
2 Weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Lens Centration - Habitual Lenses
Zeitfenster: Baseline
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.
Baseline
Lens Centration
Zeitfenster: Dispense
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.
Dispense
Lens Centration
Zeitfenster: 2 Weeks
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.
2 Weeks
Lens Movement - Habitual Lenses
Zeitfenster: Baseline
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.
Baseline
Lens Movement
Zeitfenster: Dispense
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Lens Movement
Zeitfenster: 2 Weeks
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.
2 Weeks
Overall Fit Acceptance
Zeitfenster: Baseline
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.
Baseline
Overall Fit Acceptance
Zeitfenster: Dispense
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Overall Fit Acceptance
Zeitfenster: 2 Weeks
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.
2 Weeks
Visual Acuity
Zeitfenster: Baseline
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.
Baseline
Visual Acuity
Zeitfenster: Dispense
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dispense
Visual Acuity
Zeitfenster: 2 Weeks
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.
2 Weeks
Anterior Ocular Physiological Response
Zeitfenster: Baseline
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.
Baseline
Anterior Ocular Physiological Response
Zeitfenster: 2 Weeks
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.
2 Weeks
Average Wearing Time
Zeitfenster: Baseline
Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.
Baseline
Average Wearing Time
Zeitfenster: 2 Weeks
Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.
2 Weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

CooperVision, Inc.

Ermittler

  • Hauptermittler: Lyndon Jones, CCLR, University of Waterloo
  • Hauptermittler: Meng Lin, CRC, University of California Berkeley
  • Hauptermittler: Jan Bergmanson, TERTC, University of Houston
  • Hauptermittler: Pete Kollbaum, CORL, Indiana University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2013

Primärer Abschluss (Tatsächlich)

1. April 2014

Studienabschluss (Tatsächlich)

1. Dezember 2014

Studienanmeldedaten

Zuerst eingereicht

6. Februar 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Februar 2014

Zuerst gepostet (Schätzen)

12. Februar 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Dezember 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. November 2017

Zuletzt verifiziert

1. Juni 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CV-13-47

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren